INI
349 FDA 510(k) clearances · Product code
76 daysmedian time to decision
275 days90th percentile
349clearances measured
FDA profile
- Official device name
- Vehicle, Motorized 3-Wheeled
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3800
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2021: 41 · 2022: 41 · 2023: 32 · 2024: 31 · 2025: 27 · 2026: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IERO Mobility Scooter (IERO-01) (K261232) | Jochu Technology Co., Ltd. | 2026-07-14 |
| Mobility Scooter (R200) (K261163) | Yongkang Ruihe Metal Product Co., Ltd. | 2026-07-07 |
| Virgo Mobility Scooter (Virgo-D,Virgo-F) (K253257) | Jiangsu Intco Medical Products Co., Ltd. | 2026-06-08 |
| Scooter (YD-03) (K253600) | Yurob Rehabilitation Medical Co., Ltd. | 2026-06-03 |
| Mobility Scooter (Air Carbon) (K260717) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-05-20 |
| Mobility Scooter (X-12, X-14, X-17) (K260237) | Wuyi Aichi Industry and Trade Co., Ltd. | 2026-04-22 |
| Electrical Scooter (SM4226) (K252813) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | 2026-03-17 |
| Power Mobility Scooter (MJMA01, MJMA02) (K253936) | Nanjing Mijo Technology Co., Ltd. | 2026-03-12 |
| Mobility Scooter (CL-Q3, CL-Q4) (K253631) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | 2026-02-23 |
| Mobility Scooter (S3) (K253643) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-18 |
| Electric Scooter (DDF100) (K252275) | Zhejiang Nysin Medical Co., Ltd. | 2026-01-29 |
| Electric Scooter (Mojo-T580) (K252347) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 |
| Electric Scooter (Mojo-T330) (K252349) | Dongguan Smarfody Mobility Technology Co., Ltd. | 2026-01-29 |
| Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) (K253075) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2026-01-09 |
| Mobility Scooter (BC-MS310) (K252817) | Ningbo Baichen Medical Devices Co., Ltd. | 2026-01-02 |
| Electric Scooter (S202572J, S2060, M2089, S2050) (K252835) | Guangdong Prestige Technology Co., Ltd. | 2025-12-23 |
| Mobility Scooter (T5) (K252588) | Zhejiang Taotao Vehicle Co., Ltd. | 2025-12-04 |
| Powered Mobility Scooter (PMS105, GUT177, GCAT047) (K252590) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-11-21 |
| Folding Mobility Scooter (KD101) (K252502) | Nanjing Kangni Smart Technology Co., Ltd. | 2025-10-06 |
| Mobility Scooter (BBR-Q40-01); Mobility Scooter (BBR-Q40-02); Mobility Scooter (BBR-Q40-03); Mobility Scooter (BBR-Q40-04); Mobility Scooter (BBR-Q40-05); Mobility Scooter (BBR-Q40-06) (K251799) | Jiangsu Bangbang Intelligent Technology Co., Ltd. | 2025-09-30 |
| Mobility Scooter (MS160C) (K251638) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-07-22 |
| Mobility Scooter (JT10) (K243102) | Jiangxi Jiangte Electric Vehicle Co., Ltd. | 2025-06-18 |
| Magnesium alloy scooter (RS100) (K250533) | Taizhou Reach Technology Co., Ltd. | 2025-05-14 |
| Mobility Scooter (Model X-01, X-02) (K242975) | Wuyi Aichi Industry & Trade Co., Ltd. | 2025-05-07 |
| Powered Mobility Scooter (K250027) | Intradin (Shanghai) Machinery Co., Ltd. | 2025-02-21 |
| Mobility Scooter (MS160A) (K242982) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2025-01-31 |
| Mobility Scooter (S-01); Mobility Scooter (S-02) (K242714) | Zhejiang Seedream Medical Equipment Co., Ltd. | 2025-01-23 |
| Electrical Scooter, WT-T4SU (K240590) | W'U'S Tech Co., Ltd. | 2025-01-08 |
| Mobility Scooter (YL-09B, YL-07) (K242139) | Yongkang Yile Vehicle Co., Ltd. | 2025-01-06 |
| WHILL Model R (K242760) | Whill, Inc. | 2025-01-06 |
| Scooter (PS30) (K242628) | Lichtmega Technology Co., Ltd. | 2024-12-20 |
| Mobility Scooter (N3473) (K242387) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-10-11 |
| Mobility Scooter (K240990) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-09-10 |
| Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) (K232692) | Intradin (Shanghai) Machinery Co., Ltd. | 2024-09-05 |
| Electric Scooter (M2085, S2091) (K240272) | Guangdong Prestige Technology Co., Ltd. | 2024-07-16 |
| Mobility Scooter (W3331) (K240008) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-06-05 |
| Mobility Scooter (W3431) (K240012) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-05-02 |
| Mobility Scooter (C4+) (K234098) | Yongkang Yile Vehicle Co., Ltd. | 2024-04-18 |
| Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) (K231472) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | 2023-07-19 |
| Mobility Scooter (Models: W3431D) (K231428) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-07-14 |
| Electric Scooter (Model: M2020) (K230001) | Guangdong Prestige Technology Co., Ltd. | 2023-07-05 |
| ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX) (K222703) | Moving Life, Ltd. | 2023-05-19 |
| Electric Scooter (Model: S3312) (K230615) | Guangdong Prestige Technology Co., Ltd. | 2023-05-05 |
| Electrical Scooter, WT-T4QP2 (K222729) | Wu’S Tech Co., Ltd. | 2023-03-28 |
| Mobility Scooter (Models: W3431Q, W3431R) (K222507) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2023-02-28 |
| eFOLDi Scooter, Lite (K223492) | Suntech UK , Ltd. | 2023-02-22 |
| HS186B Scooter (K222711) | Suzhou Master Machinery Manufacturing Co.,Ltd | 2023-01-09 |
| Mobility Scooter, Model: W3331F (K222495) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-10-17 |
| Auto Folding Scooter, S21F (K220227) | Heartway Medical Products Co., Ltd. | 2022-10-12 |
| Electric Scooter (K212090) | Anhui Jbh Medical Apparatus Co., Ltd. | 2022-04-22 |
| Mobility Scooter, Model W3468 (K220207) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-03-24 |
| Mobility Scooter (K220206) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2022-03-24 |
| i3 Foldable Mobility Scooter (K191356) | Puc Perfect Union Co., Ltd. | 2022-01-11 |
| Scooter (Model: FDB01) (K201196) | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | 2021-06-25 |
| Solax Electric Scooter (Models: S204311M, S204161, S204143) (K190737) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-05-10 |
| Solax Electric Scooter (K192190) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-04-23 |
| Solax Electric Scooter (Model: S202261B) (K202549) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-02-26 |
| Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) (K191897) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-02-10 |
| Wu's Electrical Scooter (K192308) | Wu'S Tech Co., Ltd. | 2020-12-21 |
| C.T.M. Mobility Scooter HS-268 (K192885) | Chien TI Enterprise Co., Ltd. | 2019-12-09 |
| SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) (K182631) | Eurogreen International, Inc. | 2019-09-19 |
| Scooter (K182471) | Tianjin Kepler Vehicle Industry Co. , Ltd. | 2019-07-10 |
| Scooter, Model: R-100 (K182411) | Yongkang Dingchang Industry & Trade Co., Ltd. | 2019-06-24 |
| C.T.M Mobility Scooter (K181344) | Chien TI Enterprise Co., Ltd. | 2018-12-14 |
| Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 (K172440) | Dongguan Prestige Sporting Goods., Ltd. | 2018-07-13 |
| Lite (K172409) | Tzora Active Systems , Ltd. | 2018-05-02 |
| Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350 (K170634) | Advanced Vehicle Concepts , Ltd. | 2017-11-29 |
| Quingo Flyte Mobility Scooter (K171256) | Agile Distributors, LLC | 2017-06-08 |
| C.T.M. Mobility Scooter (K162952) | Chien TI Enterprise Co., Ltd. | 2017-05-03 |
| KYMCO EQ10D Scooter (K163201) | Kwang Yang Motor Co., Ltd. | 2017-03-16 |
| Titan 3W (K160835) | Tzora Active Systems , Ltd. | 2017-02-02 |
| ATTO Mobility Scooter (K160909) | Moving Life, Ltd. | 2016-10-04 |
| HEARTWAY Power Mobility Scooter (K151656) | Heartway Medical Products Co., Ltd. | 2015-11-25 |
| HEARTWAY Power Mobility Scooter (K150998) | Heartway Medical Products Co., Ltd. | 2015-09-29 |
| HEARTWAY Power Mobility Scooter, BRIO S19 (K150987) | Heartway Medical Products Co., Ltd. | 2015-09-22 |
| SupaScoota Motorized vehicle (K143557) | Eurogreen International, Inc. | 2015-09-16 |
| Luggie Super (K151944) | Freerider Corporation | 2015-09-10 |
| Titan (K150086) | Tzora Active Systems , Ltd. | 2015-08-05 |
| Merits Yoga Power Scooter, S542 (K142912) | Merits Health Products Co., Ltd. | 2015-06-23 |
| MERITS TRANSFORMER POWER SCOOTER, S941 (K142162) | Merits Health Products Co., Ltd. | 2015-05-01 |
| FREERIDER FR1, models FR1-13, FR1-15, FR1-17 (K133187) | Freerider Corp | 2015-01-08 |
| HEARTWAY POWER MOBILITY SCOOTER (K132855) | Heartway Medical Products Co., Ltd. | 2014-08-29 |
| SOLAX (K131302) | Dongguan Prestige Sporting Goods Co., Ltd. | 2013-11-26 |
| KYMCO EQ20C SCOOTER (K130940) | Kwang Yang Motor Co., Ltd. | 2013-10-07 |
| PRESTIGE-MOBIE (K122749) | Prestige Sporting Goods Co. , Ltd. | 2012-12-27 |
| FREERIDER MODEL LUGGIE MODEL 168-4IT (K110165) | Freerider Luggie Scooters, Inc. | 2011-09-30 |
| LOTUS BLAKE ESTEEM SCOOTER (K103771) | Letrix Power Hangzhou Pty, Ltd. | 2011-05-06 |
| C.T.M. MOBILITY SCOOTER HS515(3W) (K110567) | C.T.M. Homecare Product, Inc. | 2011-04-22 |
| C.T.M. MOBILITY SCOOTER - MODEL HS 118 (K110395) | C.T.M. Homecare Product, Inc. | 2011-04-22 |
| BREEZE C MODEL C (3W), BREEZE C (4W) (K102304) | Afikim Electric Vehicles | 2011-01-07 |
| ZIP'R3/ ZIP'R3 XTRA SCOOTER (K102358) | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2010-10-04 |
| ZIP'R4/ ZIP'R4 XTRA SCOOTER (K102361) | Global Fabtech Wheelchair (Shanghai) Co., Ltd. | 2010-10-04 |
| AMIGO CLASSIC FD (K101507) | Amigo Mobility Intl., Inc. | 2010-07-30 |
| HEARTWAY POWER MOBILITY SCOOTER, S11 (K101143) | Heartway Medical Products Co., Ltd. | 2010-05-26 |
| HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34 (K101142) | Heartway Medical Products Co., Ltd. | 2010-05-26 |
| HEARTWAY POWER MOBILITY SCOOTER, S12 (K092650) | Heartway Medical Products Co., Ltd. | 2009-10-09 |
| HEARTWAY POWER MOBILITY SCOOTER, S8 (K092155) | Heartway Medical Products Co., Ltd. | 2009-09-21 |
| HEARTWAY POWER MOBILITY SCOOTER, S9 (K092154) | Heartway Medical Products Co., Ltd. | 2009-09-21 |
| VICTORY XL 130 FOUR WHEEL SCOOTER, MODEL SC713 (K092088) | Pride Mobility Products Corp. | 2009-07-16 |
| C.T.M. MOBILITY SCOOTER, HS-528 (K090735) | C.T.M. Homecare Product, Inc. | 2009-07-06 |
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