INI · Vehicle, Motorized 3-Wheeled
Physical Medicine · 21 CFR 890.3800 · Class 2
Overview
| Product Code | INI |
|---|---|
| Device Name | Vehicle, Motorized 3-Wheeled |
| Regulation | 21 CFR 890.3800 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 344)
Showing 20 most recent of 344 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260237 | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | Apr 22, 2026 | SESE |
| K252813 | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | Mar 17, 2026 | SESE |
| K253936 | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | Mar 12, 2026 | SESE |
| K253631 | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | Feb 23, 2026 | SESE |
| K253643 | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | Feb 18, 2026 | SESE |
| K252349 | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | Jan 29, 2026 | SESE |
| K252347 | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | Jan 29, 2026 | SESE |
| K252275 | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | Jan 29, 2026 | SESE |
| K253075 | Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | Jan 9, 2026 | SESE |
| K252817 | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | Jan 2, 2026 | SESE |
| K252835 | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | Dec 23, 2025 | SESE |
| K252588 | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | Dec 4, 2025 | SESE |
| K252590 | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | Nov 21, 2025 | SESE |
| K252502 | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. | Oct 6, 2025 | SESE |
| K251799 | 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) | Jiangsu Bangbang Intelligent Technology Co., Ltd. | Sep 30, 2025 | SESE |
| K251638 | Mobility Scooter (MS160C) | Suzhou Master Machinery Manufacturing Co.,Ltd | Jul 22, 2025 | SESE |
| K243102 | Mobility Scooter (JT10) | Jiangxi Jiangte Electric Vehicle Co., Ltd. | Jun 18, 2025 | SESE |
| K250533 | Magnesium alloy scooter (RS100) | Taizhou Reach Technology Co., Ltd. | May 14, 2025 | SESE |
| K242975 | Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. | May 7, 2025 | SESE |
| K250027 | Powered Mobility Scooter | Intradin (Shanghai) Machinery Co., Ltd. | Feb 21, 2025 | SESE |
Top Applicants
- Wu'S Tech Co., Ltd. — 16 clearances
- Heartway Medical Products Co., Ltd. — 15 clearances
- Pride Health Care, Inc. — 14 clearances
- C.T.M. Homecare Product, Inc. — 11 clearances
- Pride Mobility Products Corp. — 10 clearances
