Wheelchair, Mechanical
FDA product code IOR · Class I (low risk) · 21 CFR 890.3850 · Physical Medicine
A mechanical wheelchair is a manually 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/or require an assistive device for mobility.
463510(k) clearances
0PMA approvals
29recalls
Manufacturers
- Invacare Corp. 32
- Colours 'N Motion 12
- Freedom Designs, Inc. 10
- Sunrise Medical, Inc. 9
- Everest & Jennings, Inc. 9
- Pdg Product Design Group, Inc. 8
- Redman, Inc. 6
- Zhenjiang Assure Medical Equipment Co., Ltd. 6
- Labac Systems, Inc. 6
- Tisport 5
- Taiwan Armada Enterprise Co., Ltd. 5
- Future Mobility Healthcare, Inc. 5
- Etac Us, Inc. 5
- Fortress Litestyle 5
- Otto Bock Healthcare LP 5
- Get A Life-Give A Living Plus Kids Project, Inc. 5
- Kuschall of America 4
- Jiangsu Intco Medical Equipment & Supply Co., Ltd. 4
- Convaid Products, Inc. 4
- Major Mobility Products, Inc. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261571 | Manual Wheelchair (H008, PCK7)IOR · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 08/06/2026SE |
| K252370 | GEN 4 JOY WheelchairIOR · Traditional | Free Wheelchair Mission | 07/24/2026SE |
| K261076 | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)IOR · Traditional | GuangDong Yong Yi Rehabilitation Equipment… | 06/22/2026SE |
| K261075 | Manual Wheelchair (MS01);Manual Wheelchair (MA01)IOR · Traditional | GuangDong Yong Yi Rehabilitation Equipment… | 06/22/2026SE |
| K260849 | Icon 35; Icon 45; Icon 60; Icon 30FAFIOR · Traditional | Rehasense USA, Inc. | 06/11/2026SE |
| K260642 | Manual Wheelchair (LW01108)IOR · Traditional | Anhui Longway Medical Technology Co., Ltd. | 06/02/2026SE |
| K260295 | Helio Kids; Apex PIOR · Traditional | Motion Composites | 05/28/2026SE |
| K254141 | Manual Wheelchair (DY01903(2))IOR · Traditional | Guangdong Dayang Medical Technology Co., Ltd. | 05/21/2026SE |
| K260121 | Manual Wheelchair (7101L, 7102LHD)IOR · Traditional | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | 04/28/2026SE |
| K260319 | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with…IOR · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 03/31/2026SE |
| K253632 | Manual Wheelchair (W50)IOR · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 01/29/2026SE |
| K251886 | EmpowerRide NAVIGATORIOR · Traditional | Empower Ride, LLC | 01/12/2026SE |
| K252828 | Manual Wheelchair (W47)IOR · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 12/05/2025SE |
| K252825 | Manual Wheelchair (W45)IOR · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | 12/05/2025SE |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2)IOR · Traditional | Suzhou Master Machinery Manufacturing Co.,Ltd | 11/21/2025SE |
| K250576 | Flexx Junior (FLX-J00, FLX-J50)IOR · Traditional | Karma Mobility Co, Ltd. | 11/04/2025SE |
| K252517 | Manual Wheelchair (SYIV100A008)IOR · Traditional | Ningbo Shenyu Medical Equipment Co.,Ltd | 10/03/2025SE |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)IOR · Traditional | Anhui Jbh Medical Apparatus Co., Ltd. | 02/28/2025SE |
| K243111 | Bowhead ERA WheelchairsIOR · Traditional | Bowhead Design Corp. | 01/10/2025SE |
| K242722 | Manual Wheelchair (MASY23)IOR · Traditional | Sichuan Ast Medical Equipment Co., Ltd. | 11/22/2024SE |
| K242560 | Manual Wheelchair (SYIV100-CA9221)IOR · Traditional | Foshan Shunkangda Medical Tech Co., Ltd. | 10/24/2024SE |
| K241460 | Manual WheelchairIOR · Traditional | Lichtmega Technology Co., Ltd. | 07/11/2024SE |
| K240120 | Merlexi Craft Bariatric series of manual wheelchairsIOR · Traditional | Turbo Wheelchair Co., Inc. | 07/05/2024SE |
| K232230 | YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F…IOR · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 10/03/2023SE |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS…IOR · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 09/15/2023SE |
| K232198 | Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S…IOR · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 09/15/2023SE |
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTLIOR · Traditional | Ki Mobility, LLC | 09/05/2023SE |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, SparkIOR · Traditional | Ki Mobility, LLC | 08/31/2023SE |
| K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchairIOR · Traditional | Sichuan Ast Medical Equipment Co., Ltd. | 08/15/2023SE |
| K231110 | Manual Wheelchair (A006)IOR · Traditional | Ningbo Shenyu Medical Equipment Co.,Ltd | 06/16/2023SE |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1IOR · Special | Zhenjiang Assure Medical Equipment Co., Ltd. | 06/05/2023SE |
| K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, XIOR · Traditional | Panthera AB | 02/16/2023SE |
| K221435 | Supertilt Plus (STP)IOR · Traditional | Power Plus Mobility | 10/28/2022SE |
| K220671 | Manual WheelchairIOR · Traditional | Hebei Ruilangde Medical Equipment Technology… | 07/21/2022SE |
| K200715 | RoughRider Aurora Manual WheelchairIOR · Traditional | Roughrider America, LLC | 06/24/2022SE |
| K213790 | Aluminum back folding wheelchair SYIV 100-LQXAL2482-407IOR · Traditional | Mobility Source Medical Technology Co., Ltd. | 03/14/2022SE |
| K200466 | Manual Wheelchair (Model W28)IOR · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 06/14/2021SE |
| K201461 | Manual Wheelchair, Model A011IOR · Traditional | Ningbo Shenyu Medical Equipment Co.,Ltd | 05/21/2021SE |
| K200135 | RGK Daily Range WheelchairsIOR · Traditional | Rgk Wheelchairs, Ltd. | 09/10/2020SE |
| K192658 | Manual WheelchairIOR · Traditional | Jerry Medical Instrument (Shanghai) Co., Ltd. | 04/01/2020SE |
| K190550 | IKON 40 Manual WheelchairIOR · Traditional | Broda Seating (Broda Lp) | 07/01/2019SE |
| K190534 | Manual Wheelchair SIVFH2A102IOR · Traditional | Jiangsu Horizon Medical Science & Technology… | 05/29/2019SE |
| K190699 | Rowheels Revolution 1.0IOR · Traditional | Rowheels, Inc. | 05/09/2019SE |
| K180309 | Manual Wheelchair W54IOR · Traditional | Jiangsu Jumao Medical Equipment Co., Ltd. | 05/03/2019SE |
| K182840 | Element Pediatric WheelchairIOR · Traditional | Leggero, LLC | 04/29/2019SE |
| K180852 | Manual WheelchairIOR · Traditional | Jiangyin Newrise Medical Equipment Co., Ltd. | 03/01/2019SE |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsIOR · Traditional | Invacare Corporation | 11/14/2018SE |
| K181795 | AST Model MA012 and MS019 Rehab WheelchairIOR · Traditional | Sichuan Ast Medical Equipment Co., Ltd. | 09/25/2018SE |
| K173360 | Athena 190IOR · Traditional | Medical Rehab Products, LLC | 05/17/2018SE |
| K170517 | Merits Model R106/R136 Rehab WheelchairIOR · Traditional | Merits Healthcare Industries (Suzhou) Co., Ltd. | 11/16/2017SE |
| K171017 | Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T…IOR · Traditional | Convaid Products, LLC | 10/18/2017SE |
| K163352 | WheelchairIOR · Traditional | Kunshan Hi-Fortune Health Products Co., Ltd. | 07/28/2017SE |
| K163432 | Stellar LEAPIOR · Traditional | Pdg Product Design Group, Inc. | 06/27/2017SE |
| K162328 | Winner Transfer WheelchairIOR · Traditional | Winner SG Pte, Ltd. | 05/11/2017SE |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual…IOR · Traditional | Invacare Corporation | 04/17/2017SE |
| K170701 | GEN_2 and GEN_3 Mechanical WheelchairsIOR · Special | Free Wheelchair Mission | 03/24/2017SE |
| K162696 | Kuschall Advance Manual WheelchairIOR · Traditional | Invacare Corporation | 12/28/2016SE |
| K162692 | Kuschall K-Series Attract Manual WheelchairIOR · Traditional | Invacare Corporation | 12/28/2016SE |
| K162686 | Kuschall Champion Manual WheelchairIOR · Traditional | Invacare Corporation | 12/28/2016SE |
| K161425 | APEX Manual WheelchairIOR · Traditional | Motion Composites | 12/05/2016SE |
| K153328 | SUNCO Mechanical Wheelchair, model SKW-9003IOR · Traditional | Danyang Sunco Machinery Co., Ltd. | 07/20/2016SE |
| K151492 | KuduIOR · Traditional | R82 A/S | 05/20/2016SE |
| K152021 | Pure TiltIOR · Traditional | Proactive Comfort, LLC | 03/31/2016SE |
| K152827 | Weely Manual WheelchairIOR · Traditional | Rupiani | 02/19/2016SE |
| K152878 | SUNTEC Mechanical Wheelchair, model ST-WL-1000IOR · Traditional | Danyang Suntec Auto Parts Co., Ltd. | 02/03/2016SE |
| K152536 | MyOn HC Manual WheelchairIOR · Traditional | Invacare Corporation | 01/05/2016SE |
| K151893 | P.R.O. CG Manual WheelchairIOR · Traditional | Freedom Designs, Inc. | 10/22/2015SE |
| K151797 | Nuocande Plastic Manual Wheelchair Model NKD L07IOR · Traditional | Ningbo Lecount Medical Technology Co., Ltd. | 08/25/2015SE |
| K143101 | Helio A7 Manual Wheelchair, Move Manual WheelchairIOR · Traditional | Motion Composites | 05/01/2015SE |
| K141691 | GEN_3IOR · Special | Free Wheelchair Mission | 12/17/2014SE |
| K140023 | ElevationIOR · Traditional | Pdg Product Design Group, Inc. | 10/16/2014SE |
| K140416 | Trekker, Trekker TransitIOR · Traditional | Convaid Products, Inc. | 09/17/2014SE |
| K130017 | Valentine Steel WheelchairIOR · Traditional | Valentine Intl. , Ltd. | 05/28/2014SE |
| K130517 | Ez Transport ChairIOR · Traditional | Harris Medical, LLC | 02/25/2014SE |
| K132257 | Manual WheelchairIOR · Traditional | Zhejiang Jiafeng Electrical & Mechanial Co., Ltd. | 02/13/2014SE |
| K133855 | Breezy EleganceIOR · Traditional | Sunrise Medical (Us), LLC | 01/31/2014SE |
| K130788 | CapellaIOR · Traditional | Future Mobility Healthcare, Inc. | 12/05/2013SE |
| K130848 | Shanghai Phoenix Mechanical WheelchairIOR · Traditional | Shanghai Phoenix Medical Equipment Co., Ltd. | 11/12/2013SE |
| K131336 | TX Wheelchair ChassisIOR · Traditional | Jcm Seating Solutions, Ltd. | 10/28/2013SE |
| K131529 | Shengguang Manual WheelchairIOR · Traditional | Pingdingshan Shenxing Healthcare Technology Co., L | 09/24/2013SE |
| K123975 | Quickie & Zippie SeriesIOR · Traditional | Sunrise Medical | 08/16/2013SE |
| K123076 | Profthand Mechanical WheelchairIOR · Abbreviated | Harmony Hill International | 08/09/2013SE |
| K113164 | Discovery Tmax Manual WheelchairIOR · Traditional | Otto Bock Healthcare LP | 03/11/2013SE |
| K120391 | MR4500 WheelchairIOR · Traditional | Wardray Premise, Ltd. | 12/21/2012SE |
| K120628 | HelioIOR · Traditional | Motion Composites | 12/19/2012SE |
| K120501 | Champ Champ TransitIOR · Traditional | Convaid Products, Inc. | 09/20/2012SE |
| K120077 | Comed K-Series Manual WheelchairIOR · Traditional | Danyang Comed Healthcare Co., Ltd. | 05/14/2012SE |
| K113713 | GEN_2 Mechanical WheelchairIOR · Traditional | Free Wheelchair Mission | 05/07/2012SE |
| K112816 | Zhenjiang Asure Mechanical WheelchairIOR · Traditional | Zhenjiang Assure Medical Equipment Co., Ltd. | 04/18/2012SE |
| K120032 | Mechanical WheelchairIOR · Traditional | Aikin Healthcare Co., Ltd. | 04/13/2012SE |
| K111636 | Rehab TNT, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab TNT and Rehab RamIOR · Traditional | Gunnell, Inc. | 04/03/2012SE |
| K112950 | Jiangsu Healthy Way Mechanicl WheelchairIOR · Traditional | Jiangsu Healthy Medical Equipment Co;Ltd | 03/28/2012SE |
| K112948 | Jiangsu Healthy Way Mechanical WheelchairIOR · Traditional | Jiangsu Healthy Way Medical Equipment Co;Ltd | 03/28/2012SE |
| K120526 | Yuyue K2 Wheelchair, Yuyue K4 WheelchairIOR · Traditional | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 03/08/2012SE |
| K111739 | Kids Rock 3 ChairIOR · Special | Pride Mobility Products Corp. | 08/12/2011SE |
| K111045 | Centro Family of Manual WheelchairsIOR · Traditional | Otto Bock Healthcare LP | 07/15/2011SE |
| K110788 | Innova WheelchairIOR · Abbreviated | Columbia Medical Manufacturing, LLC | 05/06/2011SE |
| K110985 | Icon Adult ManualIOR · Traditional | Icon Wheelchairs, Inc. | 05/03/2011SE |
| K103212 | RoughriderIOR · Traditional | Whirlwind Wheelchair International | 01/03/2011SE |
| K103073 | Super Chair for Kids by OrionIOR · Traditional | Future Mobility Healthcare, Inc. | 01/03/2011SE |
| K102910 | Model Luna Manual WheelchairIOR · Traditional | P.D.G., Inc. | 12/23/2010SE |
| K102061 | Trevair Chair AdultIOR · Traditional | Patmont Motor Werks, Inc. | 12/13/2010SE |
| K102110 | 24 Widen Wheelchair (JY/CT-H28), 18 Reclining Wheelchair (JY-260), 18 Light Weight…IOR · Traditional | Foshan Shunde Jaeyong Hardware Co., Ltd. | 10/26/2010SE |
| K102031 | Galaxy LiteIOR · Traditional | Future Mobility Healthcare, Inc. | 10/20/2010SE |
| K101999 | Kaiyang Steel WheelchairIOR · Traditional | Guangdong Kaiyang Medical Technology Co., Ltd. | 10/04/2010SE |
| K101998 | Kaiyang Aluminum WheelchairIOR · Traditional | Guangdong Kaiyang Medical Technology Co., Ltd. | 10/04/2010SE |
| K101719 | Tacamo Manual WheelchairIOR · Abbreviated | Dalton Instrument Corp. | 08/25/2010SE |
| K101217 | Mac-Mobile Aquatic ChairIOR · Traditional | Rehamed Intl., LLC | 06/23/2010SE |
| K101277 | Orion II (Heavy Duty 350 LBS and 500 LBS)IOR · Special | Future Mobility Healthcare, Inc. | 06/04/2010SE |
| K100824 | Mechanical Wheelchair, Model DS 202-SIOR · Traditional | Suzhou KD Medical | 05/25/2010SE |
| K100084 | Multi Frame WheelchairIOR · Traditional | R82 A/S | 04/12/2010SE |
| K094047 | 18 Standard Wheelchair, Model MS005-4, 18 Reclining Wheelchair , Model MS008-1, 14…IOR · Traditional | Modern Rehabilitation Solutions Co., Ltd. | 03/22/2010SE |
| K091482 | Huayi K-Series Lightweight Wheelchair K3/K4IOR · Traditional | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 07/06/2009SE |
| K091478 | Trevair ChairIOR · Traditional | Patmont Motor Werks, Inc. | 06/18/2009SE |
| K083847 | Marvel Pediatric WheelchairIOR · Traditional | Rogue Wheelchairs, Inc. | 01/30/2009SE |
| K083231 | Panthera Mechanical Wheelchair, Models S2, U2, Bambino, Micro, BTIOR · Traditional | Panthera Production AB | 01/26/2009SE |
| K083044 | Hubang, Model HBL13/HBG12-SIOR · Traditional | Shanghai Hubang Medical Appliances Co., Ltd. | 12/12/2008SE |
| K082970 | Marvel Wheelchair, Model EDCAL01IOR · Traditional | Rogue Wheels, Inc. | 12/12/2008SE |
| K082314 | Bravoracer Pediatric Manual WheelchairIOR · Traditional | Otto Bock Healthcare LP | 10/28/2008SE |
| K082784 | Jumao Manual WheelchairIOR · Traditional | Danyang Jumao Healthcare Equipment Co., Ltd. | 10/07/2008SE |
| K082246 | Dignity 100IOR · Traditional | Dignity Medical Devices, Inc. | 09/09/2008SE |
| K082274 | Haida Model HD11 Manual WheelchairIOR · Traditional | Jiangyin East China Medical Technology Co., Ltd. | 08/19/2008SE |
| K081665 | Millenium IIIOR · Traditional | Next Mobility, LLC | 06/27/2008SE |
| K080506 | Martin Chair, Model C4S1IOR · Abbreviated | Martin Manufacturing Co., LLC | 06/09/2008SE |
| K080270 | Manual Rigid Mobility WheelchairIOR · Traditional | Freedom Designs, Inc. | 04/16/2008SE |
| K080880 | RTM and OvalIOR · Traditional | Next Mobility, LLC | 04/09/2008SE |
| K080207 | Danyang Huayi K2 and K7 WheelchairsIOR · Traditional | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 03/12/2008SE |
| K080114 | Huayi H035 Basic WheelchairIOR · Traditional | Danyang Huayi Medical Supply & Equipment Co, Ltd. | 02/15/2008SE |
| K073512 | Start JuniorIOR · Traditional | Otto Bock Healthcare LP | 01/14/2008SE |
| K072311 | Tilite Aero XIOR · Abbreviated | Tisport, LLC | 09/21/2007SE |
| K072153 | Quickie QX Manual Folding WheelchairIOR · Traditional | Sunrise Medical, Inc. | 09/10/2007SE |
| K071444 | Mechanical Wheelchair - L-Frame SeriesIOR · Traditional | Colours 'N Motion | 07/27/2007SE |
| K070176 | Maxhealth Mechanical Wheelchair, K1IOR · Traditional | Maxhealth Corp. | 03/01/2007SE |
| K063736 | Fuze Mechanical Wheelchair, Models T20 and T50IOR · Traditional | Pdg Product Design Group, Inc. | 01/17/2007SE |
| K062660 | CatalysyIOR · Traditional | Ki Mobility, LLC | 10/24/2006SE |
| K062309 | Karma Manual Wheelchair, Models S-Ergo 305 and S-Ergo 105IOR · Traditional | Karma Medical Products Co., Ltd. | 10/10/2006SE |
| K062311 | Karma Manual Wheelchair, Model Budget 800IOR · Traditional | Karma Medical Products Co., Ltd. | 10/04/2006SE |
| K062218 | Jan Mao Wheelchair, Models JMC612-FL318EPP and JMC612-FL418EPPIOR · Traditional | Jan Mao Industries Co., Ltd. | 08/16/2006SE |
| K061810 | Cougar WheelchairIOR · Traditional | R82 A/S | 08/07/2006SE |
| K061694 | Medcare Mechanical Wheelchair, Models MC-281S & MC-200SIOR · Traditional | Medcare Manufacturing, Inc. | 07/05/2006SE |
| K061475 | Astrotilt Manual WheelchairIOR · Traditional | Pdg Product Design Group, Inc. | 06/14/2006SE |
| K061273 | 7000 Series Lightweight Wheelchair, Models 7160L, 7180L and 7200LIOR · Traditional | Nova Ortho-Med, Inc. | 05/23/2006SE |
| K061010 | Future Mobility Healthcare Inc. Orion II Wheelchair and Stellato Mechanical WheelchairIOR · Traditional | Future Mobility Healthcare, Inc. | 05/23/2006SE |
| K060926 | TripodIOR · Traditional | Freedom Designs, Inc. | 05/19/2006SE |
| K061186 | FlightIOR · Traditional | Aero Innovative Research, Inc. | 05/12/2006SE |
| K060582 | Invacare Topaz Bariatric Manual WheelchairIOR · Special | Invacare Corporation | 03/16/2006SE |
| K060251 | WH Convertible Lightweght Wheelchair, Model WHL100IOR · Traditional | Well Home Health Products Co. | 03/08/2006SE |
| K053574 | Medline Pediatric WheelchairsIOR · Traditional | Medline Industries, Inc. | 01/25/2006SE |
| K052548 | Urok Rocking Wheelchair, Model 700-4XXIOR · Traditional | Amg Medical, Inc. | 01/06/2006SE |
| K052586 | A & I Pediatric Wheelchairs, Models RWAL2006-12, LT3207-12. a & I Bariatric Wheelchairs…IOR · Traditional | Taiwan an I Co., Ltd. | 12/09/2005SE |
| K052681 | Start Family of Manual Wheelchairs (Basic, Plus, Multi and Hemi)IOR · Traditional | Otto Bock Healthcare LP | 10/06/2005SE |
| K052468 | YK9000 Series Manual WheelchairIOR · Traditional | Intco Metal Products (Zhenjiang) Co., Ltd. | 10/05/2005SE |
| K052521 | Nissin Series Mechanical WheelchairIOR · Traditional | Nissin Medical Industries Co., Ltd. | 09/26/2005SE |
| K051369 | Syryker Sorano WheelchairIOR · Traditional | Stryker Canada | 09/26/2005SE |
| K051302 | Excel Bariatric or Excel Shuttle WheelchairIOR · Traditional | Medline Industries, Inc. | 08/15/2005SE |
| K051482 | Jan Mao Wheelchair, Model JMC612-F18EPPIOR · Traditional | Jan Mao Industries Co., Ltd. | 06/29/2005SE |
| K051481 | Jan Mao Wheelchair, Model JMC611-F18EPPIOR · Traditional | Jan Mao Industries Co., Ltd. | 06/29/2005SE |
| K051090 | X-ChangeIOR · Traditional | Meyra | 05/13/2005SE |
| K050941 | Brix WheelchairIOR · Traditional | Meyra, Inc. | 05/05/2005SE |
| K050708 | Lerado, Avanticare Mechanical Wheelchair, MR-9000IOR · Traditional | Lerado Oversea Ltd. Twn Branch (Bvi) | 04/26/2005SE |
| K050691 | R. Poon Medical Products WheelchairsIOR · Traditional | R. Poon Medical Products Co., Ltd. | 04/21/2005SE |
| K050560 | EurochairIOR · Traditional | Meyra, Inc. | 04/21/2005SE |
| K050707 | Lerado, Avanticare Transport Wheelchair, MT-3000IOR · Traditional | Lerado Oversea Ltd. Twn Branch (Bvi) | 04/18/2005SE |
| K050281 | Transport Series Transport ChairIOR · Traditional | Access Point Medical, LLC | 04/11/2005SE |
| K050280 | Runabout WheelchairIOR · Traditional | Access Point Medical, LLC | 04/11/2005SE |
| K050279 | AXS-1 Lite WheelchairIOR · Traditional | Access Point Medical, LLC | 04/11/2005SE |
| K050345 | Cie Foldaway WheelchairIOR · Traditional | Carlsbad International Export, Inc. | 03/29/2005SE |
| K050290 | Lerado, CoscoIOR · Traditional | Lerado Oversea Ltd. Twn Branch (Bvi) | 02/18/2005SE |
| K043332 | Wheelchair, Model 8500-IIIOR · Traditional | Cycling and Health Tech. Industry R&D Center | 12/13/2004SE |
| K042652 | Taiwan King Strong TC 04 MechanicalwheelchairIOR · Traditional | Taiwan King Strong Co., Ltd. | 11/04/2004SE |
| K042444 | Litestream 500EIOR · Traditional | Pride Mobility Products Corp. | 10/21/2004SE |
| K042401 | Vari-Able Apb (Adaptable Positioning Base)IOR · Traditional | American Track Roadsters, Inc. | 10/07/2004SE |
| K042304 | Chunc Junior Model# SM 242, Chunc Adapt Model# SM 251IOR · Traditional | Spectris Technologies, Inc. | 09/08/2004SE |
| K041465 | Sinon SN-L402 Lightweight WheelchairIOR · Traditional | Sinon Corporation | 07/23/2004SE |
| K041814 | FS Series WheelchairIOR · Traditional | Foshan Dongfang Medical Equipment Manufactory(Ltd) | 07/20/2004SE |
| K041337 | Pro Walker ML-300 Foldable WheelchairIOR · Traditional | Pro Walker, Inc. | 05/28/2004SE |
| K040677 | Combi Self Propelled Shower CommodeIOR · Traditional | Kjaerulff Rehabilitation A/S | 05/20/2004SE |
| K041072 | Kuschall Champion, Kuschall Compact, Kuschall Ultra-LightIOR · Traditional | Invacare Corporation | 05/12/2004SE |
| K040622 | Freedom HPIOR · Traditional | Freedom Designs, Inc. | 04/16/2004SE |
| K040561 | Manual Wheelchair SeriesIOR · Traditional | Shanghai Wheelchair Factory | 03/31/2004SE |
| K033460 | Cheetah WheelchairIOR · Traditional | R82 A/S | 03/26/2004SE |
| K033031 | Taiwan King Strong TC 03 Mechanical WheelchairIOR · Traditional | Taiwan King Strong Co., Ltd. | 12/02/2003SE |
| K033141 | Mechanical WheehchairIOR · Traditional | Pacific Medical Suppliers, Inc. | 10/30/2003SE |
| K033125 | HandivippIOR · Traditional | Handinor USA, Inc. | 10/30/2003SE |
| K032731 | Merlexi Craft Series of Manual (Mechanical) WheelchairsIOR · Abbreviated | Turbo Wheelchair Co., Inc. | 10/30/2003SE |
| K032402 | Rodeo Model, RD12, RD14, RD16, Radio Transit Model, RD12T, RD14T, RD16T,IOR · Traditional | Convaid Products, Inc. | 09/24/2003SE |
| K032123 | Shockwave Suspension WheelchairIOR · Traditional | Per4max Medical, LLC | 07/31/2003SE |
| K031910 | Stainless Steel Aquatic WheelchairIOR · Traditional | Db Perks & Associates , Ltd. | 07/25/2003SE |
| K032133 | Broda Model 587 Manual WheelchairIOR · Traditional | Broda Ent., Inc. | 07/21/2003SE |
| K030017 | ChumpIOR · Traditional | Colours 'N Motion | 05/01/2003SE |
| K023993 | Galaxy Series WheelchairIOR · Traditional | Evermed Corp. | 12/27/2002SE |
| K024055 | Tilite EvoIOR · Traditional | Tisport, LLC | 12/20/2002SE |
| K024030 | Millennium Series Manual WheelchairsIOR · Traditional | Evermed Corp. | 12/12/2002SE |
| K023574 | GizmoIOR · Traditional | Freedom Designs, Inc. | 12/04/2002SE |
| K023606 | Tilite Yg and Tilite YgsIOR · Traditional | Tisport | 11/19/2002SE |
| K023005 | Aquilla Modular WheelchairIOR · Traditional | Haywood Vocational Opportunities | 10/18/2002SE |
| K022924 | Sherpa Mobility System (Manual Wheelchair)IOR · Traditional | Otto Back Healthcare, LP | 10/17/2002SE |
| K022825 | Manual WheelchairIOR · Traditional | Major Mobility Products, Inc. | 09/13/2002SE |
| K022700 | Deluxe Manual Wheelchair HW 4000IOR · Traditional | Forever Young Ent. Co., Ltd. | 09/13/2002SE |
| K022699 | Transfer Companion HR 3000 Manual WheelchairIOR · Traditional | Forever Young Ent. Co., Ltd. | 09/13/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0264-2022 Class II | Permobil TiLite, Models: Aero Z, and ZRASome affected wheelchairs, with transit tie downs, that are used as a passenger seat in a motor vehicle may… | TiSport, Llc | 09/24/2021Open, Classified |
| Z-2294-2019 Class II | TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and…The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards. | TiSport, Llc | 09/11/2018Terminated |
| Z-2290-2016 Class II | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of…There is an observed failure of the backrest bracket which can fatigue over the life time of the product.… | Sunrise Medical (US) LLC | 07/01/2016Terminated |
| Z-1025-2016 Class II | Karma Flexx Wheelchair Manual Wheelchair.Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding… | Karman Healthcare Inc | 01/27/2016Terminated |
| Z-2467-2015 Class II | Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO…Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may… | Sunrise Medical (US) LLC | 07/27/2015Terminated |
| Z-2466-2015 Class II | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO…Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may… | Sunrise Medical (US) LLC | 07/27/2015Terminated |
| Z-1020-2015 Class II | Quickie Q7 Adult Rigid Wheelchair Model EIR4.There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on… | Sunrise Medical (US) LLC | 12/19/2014Terminated |
| Z-1019-2015 Class II | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on… | Sunrise Medical (US) LLC | 12/19/2014Terminated |
| Z-0216-2015 Class II | Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This…Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several… | Silver Star Brands | 10/10/2014Terminated |
| Z-0453-2014 Class II | Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller)…There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens… | Sunrise Medical (US) LLC | 11/11/2013Terminated |
| Z-0503-2015 Class II | Crocodile (size 3) are two-armed, wheeled walking aids, used by children with…The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge. | Snug Seat Inc | 08/26/2013Terminated |
| Z-0809-2013 Class II | Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab…The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and… | Chenica Inc. | 01/18/2013Terminated |
| Z-0785-2013 Class II | Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person…The potential exists for the wheel to rotate freely despite engagement of hub brake. | Invacare Corporation | 09/10/2012Terminated |
| Z-2113-2012 Class II | Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4)…Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states… | Sunrise Medical (US) LLC | 06/26/2012Terminated |
| Z-2695-2014 Class II | Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 JrThe hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and… | Pdg Product Design Group Inc | 06/12/2012Terminated |
| Z-0634-2014 Class II | Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight…The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair)… | Invacare Corporation | 04/16/2012Terminated |
| Z-1103-2012 | Sunrise Medical Zippie TS wheelchair To empower physically challenged person by…One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a… | Sunrise Medical (US) LLC | 01/13/2012Terminated |
| Z-0867-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature…Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs with dynamic… | Gunnell, Inc. | 11/01/2011Terminated |
| Z-0866-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature…Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a… | Gunnell, Inc. | 11/01/2011Terminated |
| Z-0865-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature…Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a… | Gunnell, Inc. | 11/01/2011Terminated |
| Z-0864-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature…Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a… | Gunnell, Inc. | 11/01/2011Terminated |
| Z-0863-2012 | Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature…Gunnell has received complaints that the gas cylinders used in Gunnell manual wheelchairs would not hold a… | Gunnell, Inc. | 11/01/2011Terminated |
| Z-3161-2011 | TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name…The Pivot Stud Bolt comprising part of the backrest assembly of TiLite ZR Series 2 and ZRA Series 2… | TiSport, Llc | 07/05/2011Terminated |
| Z-0421-2010 | Kuschall K Junior Manual wheelchairThe handle has been breaking at a calculated weight of 65 kg which may have serious consequences (broken… | Invacare Corporation | 06/15/2009Terminated |
| Z-0831-2011 | Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is…The stabilizer bar was inadvertently omitted during the manufacturing process. | Sunrise Medical Inc | 02/02/2009Terminated |
| Z-1772-2008 | Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured…Injuries to fingers. There is a potential for users to pinch their fingers between the seat bars when… | Medline Industries Inc | 03/31/2008Terminated |
| Z-1771-2008 | Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured…Injuries to fingers. There is a potential for users to pinch their fingers between the seat bars when… | Medline Industries Inc | 03/31/2008Terminated |
| Z-1770-2008 | Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured…Fingers can get injured. There is a potential for users to pinch their fingers between the seat bars when… | Medline Industries Inc | 03/31/2008Terminated |
| Z-0137-2008 | Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod…Tip-over hazard; the Anti tipper may fail/break and the wheel chair could tip over. | Freedom Designs Inc | 05/14/2007Terminated |