Wheelchair, Powered
FDA product code ITI · Class II (moderate risk) · 21 CFR 890.3860 · Physical Medicine
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type of device is not intended to climb stairs (see product code: IMK).
588510(k) clearances
0PMA approvals
55recalls
Manufacturers
- Invacare Corp. 38
- Fortress Scientific , Ltd. 19
- Everest & Jennings, Inc. 17
- Hoveround Corp. 15
- Permobil AB 11
- Merits Health Products Co., Ltd. 10
- Sunrise Medical, Inc. 10
- A-Bec Mobility, Inc. 9
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd 9
- Imc-Heart Way LLC 9
- Teftec Corp. 8
- Motion Concepts 8
- Kunshan Hi-Fortune Health Products Co., Ltd. 8
- Heartway Medical Products Co., Ltd. 7
- Otto Bock Healthcare LP 7
- Wu'S Tech Co., Ltd. 7
- Quickie Designs, Inc. 6
- Pride Mobility Products Corp. 6
- Redman, Inc. 6
- Rolcontrol Products, Co., Inc. 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260229 | Electric wheelchair (HC819N, HC830N, HC831N)ITI · Traditional | Yongkang Hengyi Vehicle Co., Ltd. | 09/08/2026SE |
| K260053 | Power Wheelchair (OS-R-M01I)ITI · Traditional | Beijing OrionStar Technology Co., Ltd. | 09/08/2026SE |
| K261354 | Electric wheelchair (D03)ITI · Traditional | Foshan Sowell Medical Technology Co., Ltd. | 08/21/2026SE |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1)ITI · Traditional | Zhejiang Lumbre Electric Appliance Co., Ltd. | 07/10/2026SE |
| K261396 | Electric WheelchairITI · Traditional | Ningbo Resshidi Medical Devices Co., Ltd. | 07/08/2026SE |
| K261164 | Electric wheelchair (XW-LY007 )ITI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K260937 | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)ITI · Traditional | Shanghai Waylong Intelligent Technology Co.,Ltd | 06/24/2026SE |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 06/18/2026SE |
| K260335 | Electric Wheelchair (S500-6)ITI · Traditional | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 06/15/2026SE |
| K261175 | WHILL (WHILL Model C2)ITI · Traditional | Whill, Inc. | 06/12/2026SE |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 06/05/2026SE |
| K260373 | Electric Wheelchair (DF506)ITI · Traditional | Jiangsu Yveelt Medical Equipment Co., Ltd. | 06/03/2026SE |
| K253241 | Electric Wheelchair (Y207BL)ITI · Traditional | Jiangsu Intco Medical Products Co., Ltd. | 05/13/2026SE |
| K253806 | Power Wheelchair (N5919 series)ITI · Special | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 04/20/2026SE |
| K253952 | Power Wheelchair (OS-R-M01S)ITI · Traditional | Beijing OrionStar Technology Co., Ltd. | 04/07/2026SE |
| K253340 | Electric Wheelchair (AL-208S-063)ITI · Traditional | Zhongshan A&J Medical Equipment Co., Ltd. | 04/03/2026SE |
| K254206 | Power wheelchair (ZS-EW8026)ITI · Traditional | Ningbo Zhishan Medical Technology Co., Ltd. | 03/27/2026SE |
| K253980 | Electrically Powered Wheelchair (Model YC-01)ITI · Traditional | Yurob Rehabilitation Medical Co., Ltd. | 03/27/2026SE |
| K253307 | Electric wheelchairITI · Traditional | Foshan Dahao Medical Technology Co., Ltd. | 03/27/2026SE |
| K254012 | Electric Wheelchair (E201)ITI · Traditional | Nanjing CareMoving Rehabilitation Equipment… | 03/24/2026SE |
| K253849 | Electric wheelchair (JJW-7002, JJW-7003)ITI · Traditional | ZheJiang J&J Mobility Co., Ltd. | 03/20/2026SE |
| K252101 | JWG-1ITI · Traditional | Yamaha Motor Co., Ltd. | 03/19/2026SE |
| K253870 | Electric Wheelchair (MP148)ITI · Traditional | Suzhou Master Machinery Manufacturing Co.,Ltd | 03/04/2026SE |
| K253789 | Electric wheelchairITI · Traditional | Zhejiang Yikang Medical Technology Co., Ltd. | 02/25/2026SE |
| K253707 | Electric wheelchair (W1,W3)ITI · Traditional | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 02/24/2026SE |
| K253599 | Electric Wheelchair (W-A807, W-A807L)ITI · Traditional | Ningbo Shenyu Medical Equipment Co.,Ltd | 02/17/2026SE |
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80)…ITI · Special | Shanghai Bangbang Robotics Co., Ltd. | 01/15/2026SE |
| K251458 | Electric Wheelchair (DH01168)ITI · Traditional | Foshan Dahao Medical Technology Co., Ltd. | 01/15/2026SE |
| K251159 | Power wheelchairITI · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 12/22/2025SE |
| K252862 | Electric Wheelchair (DH01126)ITI · Traditional | Foshan Dahao Medical Technology Co., Ltd. | 12/08/2025SE |
| K252494 | Electrically powered wheelchair (KZ301B)ITI · Traditional | Nanjing Kangni Smart Technology Co., Ltd. | 12/05/2025SE |
| K252829 | Powered Wheelchair (PL001-9001)ITI · Traditional | Suzhou KD Intelligent Device Co., Ltd. | 11/12/2025SE |
| K250819 | Electric Wheelchair (Rollz Motion Electric 2M)ITI · Traditional | Rollz International BV | 11/07/2025SE |
| K252671 | Electric wheelchair (NSDS-01)ITI · Traditional | Hebei Dansong Medical Technology Co., Ltd. | 11/03/2025SE |
| K251565 | Wheelchair (N817)ITI · Traditional | Zhejiang Topwe Tools Manufacturing Co.,Ltd | 10/06/2025SE |
| K252428 | Electric Wheelchair (Model P2)ITI · Traditional | Superpi Robot Co., Ltd. | 09/18/2025SE |
| K251891 | Electric Wheelchair (GY-E001)ITI · Traditional | Shandong Guyue Healthcare Appliance Co., Ltd. | 09/09/2025SE |
| K251285 | Electric Wheelchair (HG-630)ITI · Traditional | Zhejiang Automwheel Tech Co., Ltd. | 07/02/2025SE |
| K250729 | Power Wheelchair (MOB1107)ITI · Traditional | Vive Health, LLC | 07/02/2025SE |
| K251606 | Power Wheelchair (D26)ITI · Special | Anhui Jbh Medical Apparatus Co., Ltd. | 06/25/2025SE |
| K251248 | Electric Wheelchair (QDWP-A01,QDWP-B02)ITI · Traditional | Jinhua Qidian Vehicle Co., Ltd. | 06/20/2025SE |
| K250475 | Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)ITI · Traditional | Ningbo Baichen Medical Devices Co., Ltd. | 05/27/2025SE |
| K250758 | Electric Wheelchair (F309)ITI · Traditional | Changshu Pingfang Wheelchair Co., Ltd. | 05/09/2025SE |
| K243110 | eFOLDi Navigator Powerchair (STPC-A)ITI · Traditional | Suntech UK , Ltd. | 05/08/2025SE |
| K250158 | Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)ITI · Traditional | Zhe Jiang Cleisman Industry and Trade Co.,Ltd | 04/28/2025SE |
| K250748 | Klaxon (Twist); Klaxon (Twist R)ITI · Special | Klaxon-Mobility GmbH | 04/11/2025SE |
| K250366 | Electric Wheelchair (LW01301A07)ITI · Traditional | Anhui Longway Medical Technology Co., Ltd. | 04/08/2025SE |
| K242358 | Powered wheelchair (mobility robot) (M4, M4U)ITI · Traditional | Xsto Co., Ltd. | 04/03/2025SE |
| K250134 | Power Wheelchair (YH-E6011,YH-E6013A)ITI · Traditional | Ningbo Youhuan Automation Technology Co., Ltd. | 03/26/2025SE |
| K244003 | Electrically powered wheelchairITI · Traditional | Kunshan Hi-Fortune Health Products Co., Ltd. | 03/26/2025SE |
| K243970 | Portable WheelchairITI · Traditional | Intradin (Shanghai) Machinery Co., Ltd. | 03/07/2025SE |
| K241159 | Handbike Batec ElectricITI · Traditional | Batec Mobility, S.L. | 03/07/2025SE |
| K243962 | Electrically Powered WheelchairITI · Special | Kunshan Hi-Fortune Health Products Co., Ltd. | 02/12/2025SE |
| K243961 | Electrically Powered WheelchairITI · Special | Kunshan Hi-Fortune Health Products Co., Ltd. | 02/12/2025SE |
| K241641 | Electric Wheelchair (YE200)ITI · Traditional | Shenzhen Yattll Industry Co., Ltd. | 01/11/2025SE |
| K240267 | Klaxon (Twist); Klaxon (Twist R)ITI · Traditional | Klaxon Mobility GmbH | 01/10/2025SE |
| K242448 | Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36)ITI · Traditional | Anhui Jbh Medical Apparatus Co., Ltd. | 01/02/2025SE |
| K242989 | Electric Wheelchair (MODEL H)ITI · Traditional | Nanjing E-Take Medical Apparatus Co., Ltd. | 12/31/2024SE |
| K242468 | Power Wheelchair (D10, D12, D15, D17, D20, D37)ITI · Traditional | Anhui Jbh Medical Apparatus Co., Ltd. | 12/31/2024SE |
| K242252 | Power WheelchairITI · Traditional | Anhui Jbh Medical Apparatus Co., Ltd. | 12/27/2024SE |
| K243440 | Electric Wheelchair (HC820N)ITI · Traditional | Yongkang Hengyi Vehicle Co., Ltd. | 12/19/2024SE |
| K242327 | Empulse M90ITI · Traditional | Concourse Assistive Technology Pty, Ltd. | 12/10/2024SE |
| K242308 | Power wheelchairITI · Traditional | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 11/27/2024SE |
| K241588 | Electric Wheelchair (KR8803)ITI · Traditional | Zhejiang Kairui Medical Device Co., Ltd. | 11/25/2024SE |
| K241529 | Powered Wheelchair (NXN20-209)ITI · Traditional | Zhejiang Nysin Medical Co., Ltd. | 11/22/2024SE |
| K241603 | Powered Wheelchair (NXN20-208, NXN20-211)ITI · Traditional | Zhejiang Nysin Medical Co., Ltd. | 11/20/2024SE |
| K242471 | Power Wheelchair (W5538)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 11/18/2024SE |
| K242402 | Power wheelchairITI · Traditional | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 11/18/2024SE |
| K242791 | Electric wheelchair (KR-8807)ITI · Traditional | Zhejiang Kairui Medical Device Co., Ltd. | 11/12/2024SE |
| K242430 | Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)ITI · Traditional | Soul Mobility | 11/12/2024SE |
| K241189 | Electric Wheelchair (ME23-EW16-BC200-01); Electric Wheelchair (ME23-EW16-BC200-02)ITI · Traditional | Jiaxing Xiaoxiang Medical Equipment Technology… | 10/29/2024SE |
| K241337 | Electrically powered wheelchair (HP202)ITI · Traditional | Kunshan Hi-Fortune Health Products Co., Ltd. | 10/17/2024SE |
| K241632 | Electrically powered wheelchairITI · Traditional | Kunshan Hi-Fortune Health Products Co., Ltd. | 10/16/2024SE |
| K240563 | Power Wheelchair (JJW-6001)ITI · Traditional | ZheJiang J&J Mobility Co., Ltd. | 10/08/2024SE |
| K241854 | Power WheelchairITI · Traditional | Anhui Jbh Medical Apparatus Co., Ltd. | 10/04/2024SE |
| K240331 | Electric wheelchair (YHWL002, YHWL003)ITI · Traditional | Yongkang Youha Electric Appliance Co., Ltd. | 10/01/2024SE |
| K241379 | Powered Wheelchair (NXN20-205, NXN20-205M)ITI · Traditional | Zhejiang Nysin Medical Co., Ltd. | 09/16/2024SE |
| K240638 | Power Wheelchair (YH-E7007)ITI · Traditional | Ningbo Youhuan Automation Technology Co., Ltd. | 09/16/2024SE |
| K242136 | Electric wheelchair (C001)ITI · Traditional | Zhejiang Hfizer Medical Equipment Co., Ltd. | 09/12/2024SE |
| K241723 | Electric wheelchair (W3902)ITI · Traditional | Zhejiang Richall Medical Technology Co., Ltd. | 09/05/2024SE |
| K241721 | Electric wheelchair (N3901)ITI · Traditional | Zhejiang Richall Medical Technology Co., Ltd. | 09/05/2024SE |
| K240105 | Navigator (FMNVG15); Navigator XL (FMNVX06)ITI · Traditional | Forcemech International, LLC | 08/29/2024SE |
| K240270 | Electric wheelchair (S7018)ITI · Traditional | Guangdong Prestige Technology Company Limited | 08/27/2024SE |
| K241686 | Power wheelchair (N6101)ITI · Traditional | Zhejiang Zhonglei Medical Technology Co. , Ltd. | 08/13/2024SE |
| K240079 | Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)ITI · Traditional | Suzhou Ideal Medical Co., Ltd. | 08/09/2024SE |
| K240255 | Electric Wheelchair (JLE-W01A-2023)ITI · Traditional | Zhejiang Jianrui Technology Company Limited | 08/07/2024SE |
| K240339 | Electric Wheelchair (Robooter E60) (BBR-E60-01); Electric Wheelchair (Robooter E60)…ITI · Traditional | Shanghai Bangbang Robotics Co., Ltd. | 07/22/2024SE |
| K241463 | Electric Wheelchair (MP201C); Electric Wheelchair (MP201L)ITI · Traditional | Suzhou Master Machinery Manufacturing Co.,Ltd | 07/18/2024SE |
| K241154 | Electric Wheelchair (YFWB-63)ITI · Traditional | If Health (Xiamen) Intelligent Technology Co.,Ltd | 06/28/2024SE |
| K240673 | Electric wheelchairITI · Traditional | Zhejiang Hfizer Medical Equipment Co., Ltd. | 06/20/2024SE |
| K240913 | Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)ITI · Traditional | Shanghai Hubang Intelligent Rehabilitation… | 05/31/2024SE |
| K240329 | Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)ITI · Traditional | Yongkang Youha Electric Appliance Co., Ltd. | 03/25/2024SE |
| K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)ITI · Traditional | Magic Mobility | 03/04/2024SE |
| K232783 | Power wheelchair (Model: JMPW-01W)ITI · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 01/19/2024SE |
| K231315 | Velox Power ChairITI · Traditional | Velox Manufacturing, Inc. | 01/12/2024SE |
| K230964 | Power Wheelchair (N5909)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 12/13/2023SE |
| K231508 | Power Wheelchair, W5521ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 11/09/2023SE |
| K231868 | Electric Wheelchair (Robooter E40), Model name: BBR-E40-01ITI · Traditional | Shanghai Bangbang Robotics Co., Ltd. | 10/31/2023SE |
| K232193 | Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)ITI · Traditional | Yurob Rehabilitation Medical Co., Ltd. | 09/22/2023SE |
| K232121 | Power wheelchair (Model:BC-EA8000)ITI · Traditional | Ningbo Baichen Medical Devices Co., Ltd. | 09/15/2023SE |
| K201869 | Ki Power Tilt SystemITI · Traditional | Ki Mobility, LLC | 09/05/2023SE |
| K231032 | AMP by Method Mobility, AMP Plus (or +) by Method MobilityITI · Traditional | Method Mobility | 05/10/2023SE |
| K223393 | Electric WheelchairITI · Traditional | Shanghai Bangbang Robotics Co., Ltd. | 03/16/2023SE |
| K222502 | Klick (Variants: Power, Race, Monster)ITI · Traditional | Klaxon Mobility GmbH | 12/16/2022SE |
| K220156 | Electrically Powered Wheelchair, Joy RiderITI · Traditional | Tung Keng Enterprise Co., Ltd. | 10/07/2022SE |
| K221799 | Electric Wheelchair, Model: 9000NITI · Traditional | Silver Fox Corporation Limited | 09/16/2022SE |
| K220827 | Electric WheelchairITI · Traditional | Foshan Dahao Medical Technology Co., Ltd. | 07/05/2022SE |
| K221026 | Power WheelchairITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 07/01/2022SE |
| K221438 | WHILL Model FITI · Traditional | Whill, Inc. | 06/07/2022SE |
| K221215 | e-motion M25ITI · Special | Alber GmbH | 05/24/2022SE |
| K220747 | Power Wheelchair (N5515B)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 05/12/2022SE |
| K220740 | Power Wheelchair, W5907 (Q50 R Carbon)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 05/12/2022SE |
| K212092 | Portable Folding Electric Wheelchair (Model: DC01)ITI · Traditional | Anhui Jbh Medical Apparatus Co., Ltd. | 05/06/2022SE |
| K220213 | Empulse R90ITI · Traditional | Sunrise Medical (Us), LLC | 03/30/2022SE |
| K220529 | Merits P335 Powered WheelchairITI · Abbreviated | Merits Health Products Co., Ltd. | 03/18/2022SE |
| K191105 | e-Throne Folding Wheelchair, Model: ET-12F22ITI · Traditional | Golden Motor Technology Co., Ltd. | 01/21/2022SE |
| K212503 | HP458E Electrically Powered WheelchairITI · Traditional | Kunshan Hi-Fortune Health Products Co., Ltd. | 01/18/2022SE |
| K212854 | Powered WheelchairITI · Traditional | Zhejiang Qianxi Vehicle Co., Ltd. | 01/10/2022SE |
| K211647 | HP358EA Electrically Powered WheelchairITI · Traditional | Kunshan Hi-Fortune Health Products Co., Ltd. | 01/04/2022SE |
| K213090 | Frontier Series Power WheelchairsITI · Traditional | Magic Mobility | 11/19/2021SE |
| K213383 | WHILL Model C2ITI · Traditional | Whill, Inc. | 11/09/2021SE |
| K201855 | Electrically Powered Wheelchair -Model HP358EITI · Traditional | Kunshan Hi-Fortune Health Products Co., Ltd. | 09/28/2021SE |
| K200423 | Electric Wheelchair (XW-LY001)ITI · Traditional | Yongkang Dingchang Industry & Trade Co., Ltd. | 09/22/2021SE |
| K192739 | Electric Wheelchair [Models: JRWD6010/JRWD6012]ITI · Traditional | Jerry Medical Instrument (Shanghai) Co., Ltd. | 07/13/2021SE |
| K211574 | Extreme X8ITI · Traditional | Magic Mobility | 07/09/2021SE |
| K203806 | JWX-1 Plus (Navigo 16/Navigo 24)ITI · Traditional | Yamaha Motor Co., Ltd. | 05/21/2021SE |
| K202506 | Karma Powered WheelchairITI · Traditional | Karma Medical Products Co., Ltd. | 04/19/2021SE |
| K200978 | Electric Wheelchair (Model: S7110)ITI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 04/16/2021SE |
| K202632 | Electric wheelchair (S7204/S7205)ITI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 04/08/2021SE |
| K202379 | Invacare AVIVA Storm RX Power ChairITI · Traditional | Invacare Corporation | 03/19/2021SE |
| K202482 | Y207 Electric WheelchairITI · Traditional | Jiangsu Intco Medical Products Co., Ltd. | 03/18/2021SE |
| K203083 | Magic 360 Power WheelchairITI · Traditional | Magic Mobility | 03/17/2021SE |
| K200857 | Electric wheelchair (Model: S7012)ITI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 12/17/2020SE |
| K192618 | e-Motion M25ITI · Traditional | Alber GmbH | 11/02/2020SE |
| K193599 | BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power…ITI · Traditional | 21st Century Scientific, Inc. | 09/03/2020SE |
| K192016 | Smoov O10ITI · Traditional | Alber GmbH | 05/19/2020SE |
| K182400 | Solax Powered Wheelchair (Models: S7101, S7103)ITI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 04/14/2020SE |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPITI · Traditional | Invacare Corporation | 01/02/2020SE |
| K182576 | Solax Powered WheelchairITI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 05/21/2019SE |
| K182995 | Bariatric Power Positioning System (BPPS)ITI · Traditional | Motion Concepts | 03/08/2019SE |
| K181163 | Wu's Powered WheelchairITI · Traditional | Wu'S Tech Co., Ltd. | 02/16/2019SE |
| K182946 | Invacare TDX SP2-HD with Captain's SeatITI · Special | Invacare Corporation | 12/11/2018SE |
| K181908 | Action TrackchairITI · Traditional | Action Manufacturing, Inc. | 12/03/2018SE |
| K173315 | SupaChair Powered WheelchairITI · Traditional | Eurogreen International, Inc. | 02/13/2018SE |
| K173313 | SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SPITI · Traditional | Eurogreen International, Inc. | 02/13/2018SE |
| K170787 | Powered Wheelchair DYW30A(D09)ITI · Traditional | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 08/09/2017SE |
| K170507 | Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX…ITI · Traditional | Invacare Corporation | 07/12/2017SE |
| K163204 | A08 Power wheelchairITI · Traditional | Kunshan Aoshida Electric Technology Co., Ltd. | 05/05/2017SE |
| K160139 | Luggie ChairITI · Traditional | Freerider Corporation | 03/20/2017SE |
| K161241 | e-fix E35/E36ITI · Traditional | Alber GmbH | 10/05/2016SE |
| K153636 | Liberator Powered Wheelchair with Solar CompanionITI · Traditional | Solar Mobilityllc | 09/09/2016SE |
| K160031 | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)ITI · Traditional | Sunrise Medical (Us), LLC | 07/14/2016SE |
| K151717 | twionITI · Traditional | Alber GmbH | 02/23/2016SE |
| K153543 | WHILL Model MITI · Traditional | Whill, Inc. | 02/12/2016SE |
| K152672 | Cajun Commando 4x4ITI · Traditional | Lil Critter, LLC | 01/21/2016SE |
| K151199 | SmartDrive Wheelchair Power AssistITI · Traditional | Max Mobility, LLC | 07/30/2015SE |
| K143383 | Q6 Edge EMITI · Traditional | Pride Mobility Product Corporation | 07/23/2015SE |
| K150574 | Modular Power Positioning SystemITI · Traditional | Motion Concepts | 06/30/2015SE |
| K142783 | HEARTWAY Electrically Powered Wheelchair P27ITI · Traditional | Heartway Medical Products Co., Ltd. | 06/12/2015SE |
| K142770 | Powered WheelchairITI · Traditional | Aat Alber Antriebstechnik GmbH | 06/09/2015SE |
| K143180 | F3ITI · Traditional | Permobil AB | 03/27/2015SE |
| K143014 | F5ITI · Traditional | Permobil AB | 03/25/2015SE |
| K142731 | HEARTWAY Electrically Powered WheelchairsITI · Traditional | Heartway Medical Products Co., Ltd. | 02/27/2015SE |
| K140706 | Levo MaxITI · Traditional | Levo AG | 01/21/2015SE |
| K141783 | TDX SP2 Power WheechairITI · Traditional | Invacare Corporation | 01/09/2015SE |
| K142457 | Quickie, ZippieITI · Traditional | Sunrise Medical (Us), LLC | 12/18/2014SE |
| K142027 | 888 Wnle Powered WheelchairITI · Traditional | Pihsiang Machinery Mfg. Co., Ltd. | 10/07/2014SE |
| K140204 | JWX-2ITI · Traditional | Yamaha Motor Co., Ltd. | 08/28/2014SE |
| K132856 | Heartway Power WheelchairITI · Traditional | Heartway Medical Products Co., Ltd. | 07/15/2014SE |
| K130982 | Lerado, Power WheelchairITI · Traditional | Lerado Global (Macao Commercial Offshore) Limited | 02/28/2014SE |
| K123769 | Zx-I Power Add onITI · Traditional | Spinergy, Inc. | 05/10/2013SE |
| K122741 | Hoveround TekniqueITI · Traditional | Hoveround Corp. | 05/07/2013SE |
| K122707 | Hoverround TekniqueITI · Traditional | Hoveround Corp. | 05/07/2013SE |
| K123290 | M300 & M400ITI · Traditional | Permobil AB | 04/17/2013SE |
| K122357 | Merits Model P322FWD Powered WheelchairITI · Abbreviated | Merits Health Products Co., Ltd. | 01/09/2013SE |
| K120405 | Walk on Wheels HS-3500 Electric Aisle WheelchairITI · Traditional | Walk on Wheels Australia Pty, Ltd. | 09/19/2012SE |
| K113621 | Smartdrive Wheelchair Power-AssistITI · Traditional | Max Mobility, LLC | 07/06/2012SE |
| K113577 | Merits Model R Series Positioning System for Powered WheelchairITI · Traditional | Merits Health Products Co., Ltd. | 05/08/2012SE |
| K113488 | Jazzy Elite 6ITI · Special | Pride Mobility Product Corporration | 04/18/2012SE |
| K113463 | Power WheelchairITI · Traditional | Suzhou KD Medical Appliance Co., Ltd. | 04/06/2012SE |
| K112815 | Quantum Bariatric 451ITI · Special | Pride Mobility Product Corporration | 02/29/2012SE |
| K111278 | Z10 Wheelchair Push and Brake Assist DeviceITI · Traditional | Otto Bock Healthcare LP | 09/16/2011SE |
| K111095 | Breeze Electric Transport Chair Model 1025ITI · Traditional | Electro Kinetic Technologies, LLC | 08/03/2011SE |
| K110036 | FX 222-02 Powered WheelchairITI · Traditional | Lanzhou Wanli Aviation Electromechanical, Inc. | 03/28/2011SE |
| K103477 | Permobil M300 / M400ITI · Traditional | Permobil AB | 03/03/2011SE |
| K102355 | Zip'R Mantis Powered WheelchairITI · Traditional | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 10/04/2010SE |
| K101611 | Relay Power WheelchairITI · Traditional | Dalton Instrument Corp. | 09/29/2010SE |
| K101524 | C2000 Powered WheelchairITI · Traditional | Otto Bock Healthcare LP | 09/29/2010SE |
| K100527 | Hoveround Teknique, Model HD-6ITI · Special | Hoveround Corp. | 03/26/2010SE |
| K100350 | Hoveround Teknique GT Power Wheelchair, Model# Teknique GTITI · Traditional | Hoveround Corp. | 03/22/2010SE |
| K100327 | Heartway Power Chair, P23ITI · Traditional | Heartway Medical Products Co., Ltd. | 03/22/2010SE |
| K092936 | Amigo Escort 7.5, Model 760001 PHSITI · Traditional | Amigo Mobility Intl., Inc. | 12/04/2009SE |
| K092961 | Jazzy FrontieITI · Special | Pride Mobility Products Corp. | 10/23/2009SE |
| K092225 | Amypower All Track Series Power WheelchairITI · Traditional | Amylior, Inc. | 10/09/2009SE |
| K092130 | Rascal We Go 250 Powered WheelchairITI · Abbreviated | Electric Mobility, LLC | 09/21/2009SE |
| K091723 | Freedom Sciences Motion Control Module Version 1.5ITI · Special | Freedom Sciences, LLC | 07/06/2009SE |
| K090350 | Extreme 4X4-X8 Power WheelchairITI · Traditional | Vestil Manufacturing Corp. | 04/10/2009SE |
| K090108 | Hoveround Teknique FWD MK4 Power WheelchairITI · Traditional | Hoveround Corp. | 03/19/2009SE |
| K083249 | Quickie RhythmITI · Special | Sunrise Medical Hhg, Inc. | 12/23/2008SE |
| K082722 | P & F Power Wheelchair, Model HC-500SBITI · Traditional | P & F Brother Ind., Corp. | 10/28/2008SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2853-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2852-2026 Class II | Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2851-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2850-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2849-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2848-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2847-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2846-2026 Class II | Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2845-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2844-2026 Class II | Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2843-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2842-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2841-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-1827-2026 Class I | WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an…Cyber vulnerability of BLE communication was found by CISA VDP program. | Whill, Inc. | 12/29/2025Open, Classified |
| Z-1826-2026 Class I | WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an…Cyber vulnerability of BLE communication was found by CISA VDP program. | Whill, Inc. | 12/29/2025Open, Classified |
| Z-2540-2025 Class I | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in…Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a… | Max Mobility LLC | 08/12/2025Open, Classified |
| Z-2539-2025 Class I | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in…Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a… | Max Mobility LLC | 08/12/2025Open, Classified |
| Z-2538-2025 Class I | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction…Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a… | Max Mobility LLC | 08/12/2025Open, Classified |
| Z-2805-2026 Class II | M5 Corpus Power Wheelchair REF,120032This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit… | Permobil Inc | 06/19/2025Open, Classified |
| Z-1117-2025 Class I | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in…Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their… | Max Mobility LLC | 12/20/2024Open, Classified |
| Z-1116-2025 Class I | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction…Due to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their… | Max Mobility LLC | 12/20/2024Open, Classified |
| Z-2795-2026 Class II | Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to… | Permobil Inc | 02/29/2024Open, Classified |
| Z-2005-2023 Class II | PushTracker E3 component utilized with the SmartDrive MX2+ Power Assist Device (Part…When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail… | Permobil | 05/10/2023Open, Classified |
| Z-2004-2023 Class II | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part…When multiple processes are running on the watch's Central Processing Unit (CPU), the application may fail… | Permobil | 05/10/2023Open, Classified |
| Z-1130-2022 Class II | Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2VThe battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory… | Invacare Corporation | 03/30/2022Open, Classified |
| Z-0447-2022 Class II | Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model…Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive… | Invacare Corporation | 11/12/2021Open, Classified |
| Z-0446-2022 Class II | Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers…Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive… | Invacare Corporation | 11/12/2021Open, Classified |
| Z-0445-2022 Class II | Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers…Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive… | Invacare Corporation | 11/12/2021Open, Classified |
| Z-1504-2021 Class II | Power WheelchairSeat baseplate pin has broken in the field. | Merits Holdings Co. dba Merits Health… | 04/01/2021Open, Classified |
| Z-1947-2020 Class II | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered…Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end… | Sunrise Medical (US) LLC | 02/13/2020Terminated |
| Z-3178-2018 Class II | Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d)…This correction decision has been made because of a potential failure of one or both backrest bars providing… | Permobil, Ab | 08/15/2018Terminated |
| Z-0006-2018 Class II | Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500There is a potential failure of the top plate assembly, which is the component that connects the seating… | Permobil, Ab | 09/01/2017Terminated |
| Z-0005-2018 Class II | Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400…There is a potential failure of the top plate assembly, which is the component that connects the seating… | Permobil, Ab | 09/01/2017Terminated |
| Z-0942-2017 Class II | TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical…The interface between the TB3 back and tilt base can separate when tilted beyond the specified angle. | Pride Mobility Products Corp | 12/01/2016Terminated |
| Z-2358-2015 Class II | Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One…The batteries used in the Invacare Pronto Air Personal Transporter models power wheelchairs have the… | Invacare Corporation | 02/02/2015Terminated |
| Z-1139-2015 Class II | Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power…If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users… | Invacare Corporation | 01/15/2015Terminated |
| Z-1138-2015 Class II | FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power…If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users… | Invacare Corporation | 01/15/2015Terminated |
| Z-1137-2015 Class II | TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power…If the slack in the wires is not routed and secured correctly, flexing of the back pan under the users… | Invacare Corporation | 01/15/2015Terminated |
| Z-2657-2014 Class II | TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning…Motion Concepts identified that there is a possibility of knee support failure occurring through fatigue of… | Motion Concepts | 08/28/2014Terminated |
| Z-2091-2014 Class II | MK5 NX Controller--Wheelchair controllerM41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed… | Invacare Corporation | 06/24/2014Terminated |
| Z-2270-2013 Class II | Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a…Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power… | Invacare Corporation | 06/04/2013Terminated |
| Z-1905-2012 Class II | TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model…Invacare Corporation decided to recall the product because of a potential risk of fire and serious injury.… | Invacare Corporation | 04/06/2012Terminated |
| Z-1201-2012 | TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT…Invacare Corporation decided to recall the product because use of this actuator could result in reduced… | Invacare Corporation | 02/10/2012Terminated |
| Z-2619-2010 | Jazzy Select 6 with XLR Port HarnessImproper set-up of the wire harness can allow wires to be pulled from their intended position and become… | Pride Mobility Products Corp | 02/01/2010Terminated |
| Z-2618-2010 | Jazzy Select with XLR Port HarnessImproper set-up of the wire harness can allow wires to be pulled from their intended position and become… | Pride Mobility Products Corp | 02/01/2010Terminated |
| Z-0579-2010 | Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR…For some Invacare chairs, the stability lock feature may not be engaging properly or consistently. If the… | Invacare Corporation | 09/15/2009Terminated |
| Z-1776-2008 | Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL…Software - Watch dog timer feature was disabled. | Pride Mobility Products Corp | 04/11/2008Terminated |
| Z-1532-2008 | Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13.Product experiences a longer than expected stopping distance, which may cause injury to the user, objects… | Sunrise Medical Inc | 01/11/2008Terminated |
| Z-1531-2008 | Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10Product experiences a longer than expected stopping distance, which may cause injury to the user, objects… | Sunrise Medical Inc | 01/11/2008Terminated |
| Z-0930-2009 | Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP…Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or… | Invacare Corporation | 11/27/2007Terminated |