Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3800](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3800) → INI — Vehicle, Motorized 3-Wheeled # INI · Vehicle, Motorized 3-Wheeled _Physical Medicine · 21 CFR 890.3800 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI ## Overview - **Product Code:** INI - **Device Name:** Vehicle, Motorized 3-Wheeled - **Regulation:** [21 CFR 890.3800](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3800) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) - **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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K260237.md) | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | Apr 22, 2026 | SESE | | [K252813](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252813.md) | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | Mar 17, 2026 | SESE | | [K253936](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K253936.md) | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | Mar 12, 2026 | SESE | | [K253631](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K253631.md) | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | Feb 23, 2026 | SESE | | [K253643](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K253643.md) | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | Feb 18, 2026 | SESE | | [K252349](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252349.md) | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | Jan 29, 2026 | SESE | | [K252347](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252347.md) | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | Jan 29, 2026 | SESE | | [K252275](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252275.md) | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | Jan 29, 2026 | SESE | | [K253075](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K253075.md) | 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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252817.md) | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | Jan 2, 2026 | SESE | | [K252835](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252835.md) | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | Dec 23, 2025 | SESE | | [K252588](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252588.md) | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | Dec 4, 2025 | SESE | | [K252590](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252590.md) | Powered Mobility Scooter (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | Nov 21, 2025 | SESE | | [K252502](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K252502.md) | Folding Mobility Scooter (KD101) | Nanjing Kangni Smart Technology Co., Ltd. | Oct 6, 2025 | SESE | | [K251799](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K251799.md) | 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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K251638.md) | Mobility Scooter (MS160C) | Suzhou Master Machinery Manufacturing Co.,Ltd | Jul 22, 2025 | SESE | | [K243102](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K243102.md) | Mobility Scooter (JT10) | Jiangxi Jiangte Electric Vehicle Co., Ltd. | Jun 18, 2025 | SESE | | [K250533](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K250533.md) | Magnesium alloy scooter (RS100) | Taizhou Reach Technology Co., Ltd. | May 14, 2025 | SESE | | [K242975](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K242975.md) | Mobility Scooter (Model X-01, X-02) | Wuyi Aichi Industry & Trade Co., Ltd. | May 7, 2025 | SESE | | [K250027](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI/K250027.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/INI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com