Vehicle, Motorized 3-Wheeled
FDA product code INI · Class II (moderate risk) · 21 CFR 890.3800 · Physical Medicine
351510(k) clearances
0PMA approvals
14recalls
Manufacturers
- Wu'S Tech Co., Ltd. 17
- Heartway Medical Products Co., Ltd. 15
- Pride Health Care, Inc. 14
- C.T.M. Homecare Product, Inc. 11
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd 11
- Pride Mobility Products Corp. 10
- Medline Industries, LP 9
- Fortress Scientific , Ltd. 8
- Merits Health Products Co., Ltd. 7
- Dongguan Prestige Sporting Goods Co., Ltd. 6
- Comfort Orthopedic Co., Ltd. 6
- Kwang Yang Motor Co., Ltd. 6
- Warepalmy Enterprise, LLC (Usa) 6
- Teh Lin Prosthetic & Orthopaedic, Inc. 6
- Amigo Mobility Intl., Inc. 6
- Lerado China Limited 5
- Invacare Corp. 5
- Tzora Active Systems , Ltd. 5
- Golden Technologies, Inc. 5
- Tung Keng Enterprise Co., Ltd. 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260176 | Mobility Scooter (W3483, W3483A)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 08/10/2026SE |
| K261232 | IERO Mobility Scooter (IERO-01)INI · Traditional | Jochu Technology Co., Ltd. | 07/14/2026SE |
| K261163 | Mobility Scooter (R200)INI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
| K253257 | Virgo Mobility Scooter (Virgo-D,Virgo-F)INI · Traditional | Jiangsu Intco Medical Products Co., Ltd. | 06/08/2026SE |
| K253600 | Scooter (YD-03)INI · Traditional | Yurob Rehabilitation Medical Co., Ltd. | 06/03/2026SE |
| K260717 | Mobility Scooter (Air Carbon)INI · Traditional | Suzhou Sweetrich Vehicle Industry Technology… | 05/20/2026SE |
| K260237 | Mobility Scooter (X-12, X-14, X-17)INI · Traditional | Wuyi Aichi Industry and Trade Co., Ltd. | 04/22/2026SE |
| K252813 | Electrical Scooter (SM4226)INI · Traditional | Lerado Zhongshan Peaceful Cove Business Trading… | 03/17/2026SE |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02)INI · Traditional | Nanjing Mijo Technology Co., Ltd. | 03/12/2026SE |
| K253631 | Mobility Scooter (CL-Q3, CL-Q4)INI · Traditional | Zhejiang Wei Ling New Energy Technology Co., Ltd. | 02/23/2026SE |
| K253643 | Mobility Scooter (S3)INI · Traditional | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 02/18/2026SE |
| K252349 | Electric Scooter (Mojo-T330)INI · Traditional | Dongguan Smarfody Mobility Technology Co., Ltd. | 01/29/2026SE |
| K252347 | Electric Scooter (Mojo-T580)INI · Traditional | Dongguan Smarfody Mobility Technology Co., Ltd. | 01/29/2026SE |
| K252275 | Electric Scooter (DDF100)INI · Traditional | Zhejiang Nysin Medical Co., Ltd. | 01/29/2026SE |
| K253075 | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air…INI · Traditional | Suzhou Sweetrich Vehicle Industry Technology… | 01/09/2026SE |
| K252817 | Mobility Scooter (BC-MS310)INI · Traditional | Ningbo Baichen Medical Devices Co., Ltd. | 01/02/2026SE |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050)INI · Traditional | Guangdong Prestige Technology Co., Ltd. | 12/23/2025SE |
| K252588 | Mobility Scooter (T5)INI · Traditional | Zhejiang Taotao Vehicle Co., Ltd. | 12/04/2025SE |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047)INI · Traditional | Intradin (Shanghai) Machinery Co., Ltd. | 11/21/2025SE |
| K252502 | Folding Mobility Scooter (KD101)INI · Traditional | Nanjing Kangni Smart Technology Co., Ltd. | 10/06/2025SE |
| K251799 | Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter…INI · Traditional | Jiangsu Bangbang Intelligent Technology Co., Ltd. | 09/30/2025SE |
| K251638 | Mobility Scooter (MS160C)INI · Traditional | Suzhou Master Machinery Manufacturing Co.,Ltd | 07/22/2025SE |
| K243102 | Mobility Scooter (JT10)INI · Traditional | Jiangxi Jiangte Electric Vehicle Co., Ltd. | 06/18/2025SE |
| K250533 | Magnesium alloy scooter (RS100)INI · Traditional | Taizhou Reach Technology Co., Ltd. | 05/14/2025SE |
| K242975 | Mobility Scooter (Model X-01, X-02)INI · Traditional | Wuyi Aichi Industry & Trade Co., Ltd. | 05/07/2025SE |
| K250027 | Powered Mobility ScooterINI · Special | Intradin (Shanghai) Machinery Co., Ltd. | 02/21/2025SE |
| K242982 | Mobility Scooter (MS160A)INI · Traditional | Suzhou Master Machinery Manufacturing Co.,Ltd | 01/31/2025SE |
| K242714 | Mobility Scooter (S-01); Mobility Scooter (S-02)INI · Traditional | Zhejiang Seedream Medical Equipment Co., Ltd. | 01/23/2025SE |
| K240590 | Electrical Scooter, WT-T4SUINI · Traditional | W'U'S Tech Co., Ltd. | 01/08/2025SE |
| K242760 | WHILL Model RINI · Traditional | Whill, Inc. | 01/06/2025SE |
| K242139 | Mobility Scooter (YL-09B, YL-07)INI · Traditional | Yongkang Yile Vehicle Co., Ltd. | 01/06/2025SE |
| K242628 | Scooter (PS30)INI · Traditional | Lichtmega Technology Co., Ltd. | 12/20/2024SE |
| K242387 | Mobility Scooter (N3473)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 10/11/2024SE |
| K240990 | Mobility ScooterINI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 09/10/2024SE |
| K232692 | Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)INI · Traditional | Intradin (Shanghai) Machinery Co., Ltd. | 09/05/2024SE |
| K240272 | Electric Scooter (M2085, S2091)INI · Traditional | Guangdong Prestige Technology Co., Ltd. | 07/16/2024SE |
| K240008 | Mobility Scooter (W3331)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 06/05/2024SE |
| K240012 | Mobility Scooter (W3431)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 05/02/2024SE |
| K234098 | Mobility Scooter (C4+)INI · Traditional | Yongkang Yile Vehicle Co., Ltd. | 04/18/2024SE |
| K231472 | Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)INI · Traditional | Suzhou Sweetrich Vehicle Industry Technology… | 07/19/2023SE |
| K231428 | Mobility Scooter (Models: W3431D)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 07/14/2023SE |
| K230001 | Electric Scooter (Model: M2020)INI · Traditional | Guangdong Prestige Technology Co., Ltd. | 07/05/2023SE |
| K222703 | ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter…INI · Traditional | Moving Life, Ltd. | 05/19/2023SE |
| K230615 | Electric Scooter (Model: S3312)INI · Traditional | Guangdong Prestige Technology Co., Ltd. | 05/05/2023SE |
| K222729 | Electrical Scooter, WT-T4QP2INI · Traditional | WuS Tech Co., Ltd. | 03/28/2023SE |
| K222507 | Mobility Scooter (Models: W3431Q, W3431R)INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 02/28/2023SE |
| K223492 | eFOLDi Scooter, LiteINI · Traditional | Suntech UK , Ltd. | 02/22/2023SE |
| K222711 | HS186B ScooterINI · Traditional | Suzhou Master Machinery Manufacturing Co.,Ltd | 01/09/2023SE |
| K222495 | Mobility Scooter, Model: W3331FINI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 10/17/2022SE |
| K220227 | Auto Folding Scooter, S21FINI · Traditional | Heartway Medical Products Co., Ltd. | 10/12/2022SE |
| K212090 | Electric ScooterINI · Traditional | Anhui Jbh Medical Apparatus Co., Ltd. | 04/22/2022SE |
| K220207 | Mobility Scooter, Model W3468INI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 03/24/2022SE |
| K220206 | Mobility ScooterINI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 03/24/2022SE |
| K191356 | i3 Foldable Mobility ScooterINI · Traditional | Puc Perfect Union Co., Ltd. | 01/11/2022SE |
| K201196 | Scooter (Model: FDB01)INI · Traditional | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 06/25/2021SE |
| K190737 | Solax Electric Scooter (Models: S204311M, S204161, S204143)INI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 05/10/2021SE |
| K192190 | Solax Electric ScooterINI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 04/23/2021SE |
| K202549 | Solax Electric Scooter (Model: S202261B)INI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 02/26/2021SE |
| K191897 | Solax Electric Scooter (Models: S3023, S3024, S3025, S3026)INI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 02/10/2021SE |
| K192308 | Wu's Electrical ScooterINI · Traditional | Wu'S Tech Co., Ltd. | 12/21/2020SE |
| K192885 | C.T.M. Mobility Scooter HS-268INI · Traditional | Chien TI Enterprise Co., Ltd. | 12/09/2019SE |
| K182631 | SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP)INI · Traditional | Eurogreen International, Inc. | 09/19/2019SE |
| K182471 | ScooterINI · Traditional | Tianjin Kepler Vehicle Industry Co. , Ltd. | 07/10/2019SE |
| K182411 | Scooter, Model: R-100INI · Traditional | Yongkang Dingchang Industry & Trade Co., Ltd. | 06/24/2019SE |
| K181344 | C.T.M Mobility ScooterINI · Traditional | Chien TI Enterprise Co., Ltd. | 12/14/2018SE |
| K172440 | Solax Electric Scooter, Models: S302121, S302131, S302141, S302151INI · Traditional | Dongguan Prestige Sporting Goods., Ltd. | 07/13/2018SE |
| K172409 | LiteINI · Traditional | Tzora Active Systems , Ltd. | 05/02/2018SE |
| K170634 | Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power…INI · Traditional | Advanced Vehicle Concepts , Ltd. | 11/29/2017SE |
| K171256 | Quingo Flyte Mobility ScooterINI · Traditional | Agile Distributors, LLC | 06/08/2017SE |
| K162952 | C.T.M. Mobility ScooterINI · Traditional | Chien TI Enterprise Co., Ltd. | 05/03/2017SE |
| K163201 | KYMCO EQ10D ScooterINI · Traditional | Kwang Yang Motor Co., Ltd. | 03/16/2017SE |
| K160835 | Titan 3WINI · Traditional | Tzora Active Systems , Ltd. | 02/02/2017SE |
| K160909 | ATTO Mobility ScooterINI · Traditional | Moving Life, Ltd. | 10/04/2016SE |
| K151656 | HEARTWAY Power Mobility ScooterINI · Traditional | Heartway Medical Products Co., Ltd. | 11/25/2015SE |
| K150998 | HEARTWAY Power Mobility ScooterINI · Traditional | Heartway Medical Products Co., Ltd. | 09/29/2015SE |
| K150987 | HEARTWAY Power Mobility Scooter, BRIO S19INI · Traditional | Heartway Medical Products Co., Ltd. | 09/22/2015SE |
| K143557 | SupaScoota Motorized vehicleINI · Traditional | Eurogreen International, Inc. | 09/16/2015SE |
| K151944 | Luggie SuperINI · Traditional | Freerider Corporation | 09/10/2015SE |
| K150086 | TitanINI · Traditional | Tzora Active Systems , Ltd. | 08/05/2015SE |
| K142912 | Merits Yoga Power Scooter, S542INI · Abbreviated | Merits Health Products Co., Ltd. | 06/23/2015SE |
| K142162 | Merits Transformer Power Scooter, S941INI · Traditional | Merits Health Products Co., Ltd. | 05/01/2015SE |
| K133187 | FREERIDER FR1, models FR1-13, FR1-15, FR1-17INI · Traditional | Freerider Corp | 01/08/2015SE |
| K132855 | Heartway Power Mobility ScooterINI · Traditional | Heartway Medical Products Co., Ltd. | 08/29/2014SE |
| K131302 | SolaxINI · Traditional | Dongguan Prestige Sporting Goods Co., Ltd. | 11/26/2013SE |
| K130940 | Kymco EQ20C ScooterINI · Traditional | Kwang Yang Motor Co., Ltd. | 10/07/2013SE |
| K122749 | Prestige-MobieINI · Traditional | Prestige Sporting Goods Co. , Ltd. | 12/27/2012SE |
| K110165 | Freerider Model Luggie Model 168-4ITINI · Traditional | Freerider Luggie Scooters, Inc. | 09/30/2011SE |
| K103771 | Lotus Blake Esteem ScooterINI · Traditional | Letrix Power Hangzhou Pty, Ltd. | 05/06/2011SE |
| K110567 | C.T.M. Mobility Scooter HS515(3W)INI · Traditional | C.T.M. Homecare Product, Inc. | 04/22/2011SE |
| K110395 | C.T.M. Mobility Scooter - Model HS 118INI · Traditional | C.T.M. Homecare Product, Inc. | 04/22/2011SE |
| K102304 | Breeze C Model C (3W), Breeze C (4W)INI · Traditional | Afikim Electric Vehicles | 01/07/2011SE |
| K102361 | ZIP'R4/ ZIP'R4 Xtra ScooterINI · Traditional | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 10/04/2010SE |
| K102358 | ZIP'R3/ ZIP'R3 Xtra ScooterINI · Traditional | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 10/04/2010SE |
| K101507 | Amigo Classic FDINI · Abbreviated | Amigo Mobility Intl., Inc. | 07/30/2010SE |
| K101143 | Heartway Power Mobility Scooter, S11INI · Traditional | Heartway Medical Products Co., Ltd. | 05/26/2010SE |
| K101142 | Heartway Lightweight Power Mobility Scooter, S34INI · Traditional | Heartway Medical Products Co., Ltd. | 05/26/2010SE |
| K092650 | Heartway Power Mobility Scooter, S12INI · Traditional | Heartway Medical Products Co., Ltd. | 10/09/2009SE |
| K092155 | Heartway Power Mobility Scooter, S8INI · Traditional | Heartway Medical Products Co., Ltd. | 09/21/2009SE |
| K092154 | Heartway Power Mobility Scooter, S9INI · Traditional | Heartway Medical Products Co., Ltd. | 09/21/2009SE |
| K092088 | Victory XL 130 Four Wheel Scooter, Model SC713INI · Special | Pride Mobility Products Corp. | 07/16/2009SE |
| K091418 | C.T.M. Mobility Scooter, Model HS-628, Invacare OrionINI · Traditional | C.T.M. Homecare Product, Inc. | 07/06/2009SE |
| K090735 | C.T.M. Mobility Scooter, HS-528INI · Traditional | C.T.M. Homecare Product, Inc. | 07/06/2009SE |
| K091212 | Wu's 3 Wheeled Electrical Scooter, WT-T3HINI · Traditional | Wu'S Tech Co., Ltd. | 05/27/2009SE |
| K090966 | Amigo Category III Full-Sized Regular Duty 3 Wheel (310000) and Amigo Category V Heavy…INI · Abbreviated | Svrc Industries, Inc. | 05/15/2009SE |
| K091113 | Maxima V, Three Wheel Scooter, Model SC900V Maxima V, Four Wheel Scooter, Model SC940VINI · Special | Pride Mobility Products Corp. | 05/11/2009SE |
| K090805 | V10, Three Wheel Scooter, Model SC610V, V10, Three Wheel Scooter, Model SC610VPS, V10…INI · Special | Pride Mobility Products Corp. | 04/03/2009SE |
| K090524 | Go Go Elite Traveler V Three Wheel Scooter, Model SC40EVINI · Special | Pride Mobility Products Corp. | 03/19/2009SE |
| K083303 | Landlex, Model: 402XINI · Traditional | Besteam Technology, Inc. | 01/26/2009SE |
| K082963 | Wu's 4-WHEELED Neo Scooter, WT-M3AINI · Traditional | Wu'S Tech Co., Ltd. | 11/24/2008SE |
| K082901 | Kymco Foru, Model EQ20INI · Traditional | Kwang Yang Motor Co., Ltd. | 10/28/2008SE |
| K082900 | Kymco Foru, Model EQ10INI · Traditional | Kwang Yang Motor Co., Ltd. | 10/28/2008SE |
| K081980 | Kymco Foru, Model EQ35INI · Traditional | Besteam Technology, Inc. | 08/04/2008SE |
| K081133 | Kymco Foru, Model EQ40INI · Traditional | Kwang Yang Motor Co., Ltd. | 06/10/2008SE |
| K080242 | Heartway Power Mobility Scooter, PF7INI · Traditional | Heartway Medical Products Co., Ltd. | 02/27/2008SE |
| K080288 | Travel Pal Four Wheel Scooter, Model MM114INI · Special | Mega Motion, Inc. | 02/15/2008SE |
| K073044 | Heartway Power Mobility Scooter, Model PT7INI · Traditional | Heartway Medical Products Co., Ltd. | 12/07/2007SE |
| K072712 | Comfort Electric Scooter, LY-EW408INI · Traditional | Comfort Orthopedic Co., Ltd. | 10/31/2007SE |
| K072630 | Foru, Model EQ30INI · Traditional | Kwang Yang Motor Co., Ltd. | 10/03/2007SE |
| K072337 | Wu's 4-WHEELED Neo Scooter, Model WT-M4AINI · Traditional | Wu'S Tech Co., Ltd. | 09/21/2007SE |
| K072165 | Victory Three Wheel Scooter, Model: SC610INI · Special | Pride Mobility Products Corp. | 08/17/2007SE |
| K072104 | Heartway Power Mobility Scooter, PF6INI · Traditional | Heartway Medical Products Co., Ltd. | 08/17/2007SE |
| K071949 | Victory, 4 Wheel Scooter / Model, # SC1740INI · Special | Pride Mobility Products Corp. | 08/01/2007SE |
| K071282 | Model Segaego 4D ScooterINI · Traditional | Dalton Medical Corp. | 07/27/2007SE |
| K071284 | Model Segaego 3D ScooterINI · Traditional | Dalton Medical Corp. | 07/26/2007SE |
| K071007 | Heartway Lightweight Power Mobility Scooter, S33INI · Traditional | Heartway Medical Products Co., Ltd. | 04/19/2007SE |
| K070817 | Leradotech Scooter, Model SBINI · Traditional | Lerado China Limited | 04/13/2007SE |
| K070802 | Leradotech, Model SCINI · Traditional | Lerado China Limited | 04/13/2007SE |
| K070602 | C.T.M. Mobility Scooter# HS-265INI · Traditional | C.T.M. Homecare Product, Inc. | 04/02/2007SE |
| K070493 | Heartway Power Tilt Seating System Power Chair, P17RTINI · Traditional | Heartway Medical Products Co., Ltd. | 03/23/2007SE |
| K070603 | C.T.M. Mobilitty Scooter # HS-295INI · Traditional | C.T.M. Homecare Product, Inc. | 03/20/2007SE |
| K062646 | Ruike, Model 3411INI · Traditional | Shanghai Ruike Sports Goods Co., Ltd. | 02/05/2007SE |
| K070025 | C.T.M. Mobility Scooter, Model HS-310INI · Traditional | C.T.M. Homecare Product, Inc. | 02/01/2007SE |
| K063196 | Landlex, Model S403XINI · Traditional | Besteam Technology, Inc. | 01/23/2007SE |
| K062645 | Ruike, Model 3431INI · Traditional | Shanghai Ruike Sports Goods Co., Ltd. | 12/19/2006SE |
| K062676 | Ruike, Model 3331INI · Traditional | Shanghai Ruike Sports Goods Co., Ltd. | 12/14/2006SE |
| K063030 | Comfort Scooter Model LY-EW406INI · Traditional | Comfort Orthopedic Co., Ltd. | 12/04/2006SE |
| K063389 | Go Go Elite Traveller Plus 4 Wheel Scooter, Model SC54INI · Special | Pride Mobility Products Corp. | 11/17/2006SE |
| K063162 | Golden LitewayINI · Special | Golden Technologies, Inc. | 11/02/2006SE |
| K063032 | Comfort Scooter, Model LY-EW415INI · Traditional | Comfort Orthopedic Co., Ltd. | 10/16/2006SE |
| K062790 | Wu's 3-WHEELED Neo Scooter, Model WT-T3EINI · Traditional | Wu'S Tech Co., Ltd. | 10/11/2006SE |
| K062160 | Go Go Mini, Model SC30INI · Special | Pride Mobility Products Corp. | 09/12/2006SE |
| K061912 | FusionINI · Traditional | Burke, Inc. | 08/01/2006SE |
| K060697 | Travel Pal (MM-111B) /Mega MotionINI · Special | Mega Motion, Inc. | 04/11/2006SE |
| K060068 | Avanticare, Model SA4021INI · Traditional | Lerado China Limited | 03/08/2006SE |
| K052204 | The Elite - Ultra-Light, Compact Portable ScooterINI · Traditional | Tzora Active Systems , Ltd. | 02/15/2006SE |
| K060042 | Landlex, Model P100XINI · Traditional | Besteam Technology, Inc. | 02/14/2006SE |
| K051028 | BreezeINI · Traditional | Afikim Electric Vehicles | 01/27/2006SE |
| K052558 | VCS, Model S4TINI · Traditional | Cycling and Health Tech. Industry R&D Center/Chc | 10/27/2005SE |
| K052673 | King I Powered Scooter, Model CTL-11INI · Traditional | King I Tech Corporation | 10/17/2005SE |
| K052486 | Proasia, Model L4501INI · Traditional | Proasia Limited | 10/07/2005SE |
| K052378 | Proasia, Model L3402INI · Traditional | Proasia Limited | 10/07/2005SE |
| K051130 | VCS S3YINI · Traditional | Cycling and Health Tech. Industry R&D Center/Chc | 09/09/2005SE |
| K051473 | Leardo, Avanticare Electrical SCOOTERSM3021INI · Traditional | Lerado China Limited | 08/31/2005SE |
| K051131 | VCS S3TINI · Traditional | Cycling and Health Tech. Industry R&D Center/Chc | 08/15/2005SE |
| K051538 | Avanticare, Model SA4022INI · Traditional | Lerado China Limited | 07/21/2005SE |
| K050793 | Landlex Model S400XINI · Traditional | Cycling and Health Tech. Industry R&D Center | 07/07/2005SE |
| K050507 | Smartech, Model Holi IINI · Traditional | Cycling and Health Tech. Industry R&D Center | 07/07/2005SE |
| K051118 | Model TL-360 Power ScooterINI · Traditional | Teh Lin Prosthetic & Orthopaedic, Inc. | 05/31/2005SE |
| K051116 | Model TL-560 Power ScooterINI · Traditional | Teh Lin Prosthetic & Orthopaedic, Inc. | 05/31/2005SE |
| K050792 | Landlex, Model S300XINI · Traditional | Cycling and Health Tech. Industry R&D Center | 04/21/2005SE |
| K050042 | Wu's 4-WHEELED Neo Scooter, WT-XL4INI · Traditional | Wu'S Tech Co., Ltd. | 03/14/2005SE |
| K043326 | Bewell, Model SC 20INI · Traditional | Cycling and Health Tech. Industry R&D Center | 01/26/2005SE |
| K042104 | American Bantex, Model MS 3INI · Traditional | American Bantex Corp. | 10/21/2004SE |
| K042764 | Medline Strider Midi 4INI · Special | Medline Industries, Inc. | 10/08/2004SE |
| K042763 | Modification to Medline Strider Midi 3INI · Special | Medline Industries, Inc. | 10/07/2004SE |
| K042012 | Teh Lin Power Scooter, Model TL-822INI · Traditional | Teh Lin Prosthetic & Orthopaedic, Inc. | 09/24/2004SE |
| K042011 | Power Scooter, Model TL0821INI · Traditional | Teh Lin Prosthetic & Orthopaedic, Inc. | 09/24/2004SE |
| K042010 | Power Scooter, Model TL-688INI · Traditional | Teh Lin Prosthetic & Orthopaedic, Inc. | 09/01/2004SE |
| K041677 | Karma Scooter, Model KS-747.2INI · Traditional | Karma Medical Products Co., Ltd. | 08/05/2004SE |
| K040754 | American Bantex MS 4 Mini ScooterINI · Traditional | American Bantex Corp. | 07/23/2004SE |
| K041193 | A&I Scooter, SC-402INI · Traditional | Well Success Biotech, Inc. | 05/25/2004SE |
| K041187 | A&I Scooter, SC-301INI · Traditional | Well Success Biotech, Inc. | 05/25/2004SE |
| K041055 | Medline Strider Maxi 4INI · Traditional | Medline Industries, Inc. | 05/25/2004SE |
| K041054 | Medline Strider Maxi 3INI · Traditional | Medline Industries, Inc. | 05/25/2004SE |
| K041053 | Medline Strider Micro 3INI · Traditional | Medline Industries, Inc. | 05/25/2004SE |
| K040838 | Medline Strider Mini 4INI · Traditional | Medline Industries, Inc. | 05/07/2004SE |
| K040818 | Medline Strider Mini 3INI · Traditional | Medline Industries, Inc. | 05/07/2004SE |
| K041025 | Buzzaround, Vehicle, Motorized 3-WHEELEDINI · Special | Golden Technologies, Inc. | 05/03/2004SE |
| K040968 | Wu's 4-WHEELED Neo Scooter, Model WT-T4DINI · Traditional | Wu'S Tech Co., Ltd. | 04/30/2004SE |
| K033116 | Opti-Rider DeluxeINI · Traditional | Hansung Econet Co., Ltd. | 04/12/2004SE |
| K040097 | Medline Strider Midi 3INI · Traditional | Medline Industries, Inc. | 02/13/2004SE |
| K032446 | Medline Strider, Models Midi 3 and Midi 4INI · Traditional | Medline Industries, Inc. | 02/12/2004SE |
| K033019 | Sunpex Technologies Model SE03INI · Abbreviated | Sunpex Technology Co., Ltd. | 01/22/2004SE |
| K033240 | Be-Mobile 3-WHEELED Electric Scooter, Model DK S200INI · Traditional | Tung Keng Enterprise Co., Ltd. | 12/18/2003SE |
| K033220 | Be-Mobile 4-WHEELED Electric Scooter, Model DK S280INI · Traditional | Tung Keng Enterprise Co., Ltd. | 12/18/2003SE |
| K032645 | Justwin Scooter, JS-3014INI · Traditional | Joy Ride Tech Co., Ltd. | 12/02/2003SE |
| K032643 | Justwin Scooter, JS-3013INI · Traditional | Joy Ride Tech Co., Ltd. | 12/02/2003SE |
| K032488 | Wu's 3-WHEELED Neo Scooter, WT-T3DINI · Traditional | Wu'S Tech Co., Ltd. | 12/02/2003SE |
| K032879 | Navigator IINI · Traditional | Adaptive Healthcare Technologies, Inc. | 11/13/2003SE |
| K033239 | Be-Mobile 4-WHEELED Electric Scooter, Model DK S500INI · Traditional | Tung Keng Enterprise Co., Ltd. | 11/12/2003SE |
| K033219 | Be-Mobile 4-WHEELED Electric Scooter, Model DK S600INI · Traditional | Tung Keng Enterprise Co., Ltd. | 11/12/2003SE |
| K033204 | Esg 4-WHEEL Scooter, ESG-03INI · Traditional | Emg Technology Co., Ltd. | 11/12/2003SE |
| K032617 | Wu's 4-WHEELED Scooter, WT-L4JRINI · Traditional | Wu'S Tech Co., Ltd. | 11/12/2003SE |
| K033241 | Be-Mobile 3-WHEELED Electric Scooter, Model DK S320INI · Traditional | Tung Keng Enterprise Co., Ltd. | 11/10/2003SE |
| K033032 | Wu's 3-WHEELED Neo Scooter, Model WT-M3JRINI · Traditional | Wu'S Tech Co., Ltd. | 11/10/2003SE |
| K032919 | C.T.M. Mobility Scooter, Model HS-250INI · Traditional | C.T.M. Homecare Product, Inc. | 10/15/2003SE |
| K032918 | C.T.M. Mobility Scooter, Model HS-235INI · Traditional | C.T.M. Homecare Product, Inc. | 10/06/2003SE |
| K030757 | Coach 777-4INI · Traditional | Wheelchair & Scooter Express | 10/06/2003SE |
| K030756 | Coach 777-3INI · Traditional | Wheelchair & Scooter Express | 10/06/2003SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1505-2021 Class II | ScooterSeat baseplate pin has broken in the field. | Merits Holdings Co. dba Merits Health… | 04/01/2021Open, Classified |
| Z-1235-2014 Class II | Buzzaround XL scooters' Product Usage: mobilityBuzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper… | Golden Technologies, Inc. | 01/21/2014Terminated |
| Z-0115-2014 Class II | Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze…Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become… | S.A.E. Afikim | 09/27/2013Terminated |
| Z-0774-2012 | Leo 3-Wheel Scooter and Leo Scooter, Distributed By: Invacare Corporation, 1200 Taylor…Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to… | Invacare Corporation | 12/07/2011Terminated |
| Z-3212-2011 | Victory 10, 4 Wheel (SC710) Mobility medical deviceContract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in… | Pride Mobility Products Corp | 06/22/2011Terminated |
| Z-3211-2011 | Victory 10, 3 Wheel (SC610) Mobility medical deviceContract manufacturer error. Component part(s) (fuses) specifications were not adhered to as outlined in… | Pride Mobility Products Corp | 06/22/2011Terminated |
| Z-1941-2012 Class II | Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.The main harness connector was manufactured without the required back shield sealing protection. As a… | Pride Mobility Products Corp | 11/26/2010Terminated |
| Z-0417-2011 | Rascal UltraLite 370B manufactured by Giant Manufacturing, Taiwan.Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose… | Electric Mobility Corp | 09/27/2010Terminated |
| Z-0416-2011 | Rascal LiteWay 224 manufactured by Giant Manufacturing, Taiwan.Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose… | Electric Mobility Corp | 09/27/2010Terminated |
| Z-0415-2011 | Rascal LiteWay 214 manufactured by Giant Manufacturing, Taiwan.Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose… | Electric Mobility Corp | 09/27/2010Terminated |
| Z-0175-2008 | Rascal Scooters with Electric seat lifts, Model 600 Series, distributed between…Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding… | Electric Mobility Corp | 03/29/2007Terminated |
| Z-0174-2008 | Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an…Seat and/or lift actuator problems: 1) Models equipped with a Seat Lift, the mast screw and washer holding… | Electric Mobility Corp | 03/22/2007Terminated |
| Z-0037-2007 | Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by…Under conditions of heavy use, signs of overheating of the main battery cables have been observed. | Medline Industries Inc | 07/20/2006Terminated |
| Z-0036-2007 | Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured…Under conditions of heavy use, signs of overheating of the main battery cables have been observed. | Medline Industries Inc | 07/20/2006Terminated |