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-staging.innolitics.com/productcode/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 351)

Showing 20 most recent of 351 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260176](/device/K260176.md) | Mobility Scooter (W3483, W3483A) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Aug 10, 2026 | SESE |
| [K260094](/device/K260094.md) | Mobility Scooter (W3465, W3902 (S50 Carbon)) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Aug 10, 2026 | SESE |
| [K261232](/device/K261232.md) | IERO Mobility Scooter (IERO-01) | Jochu Technology Co., Ltd. | Jul 14, 2026 | SESE |
| [K261163](/device/K261163.md) | Mobility Scooter (R200) | Yongkang Ruihe Metal Product Co., Ltd. | Jul 7, 2026 | SESE |
| [K253257](/device/K253257.md) | Virgo Mobility Scooter (Virgo-D,Virgo-F) | Jiangsu Intco Medical Products Co., Ltd. | Jun 8, 2026 | SESE |
| [K253600](/device/K253600.md) | Scooter (YD-03) | Yurob Rehabilitation Medical Co., Ltd. | Jun 3, 2026 | SESE |
| [K260717](/device/K260717.md) | Mobility Scooter (Air Carbon) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | May 20, 2026 | SESE |
| [K260237](/device/K260237.md) | Mobility Scooter (X-12, X-14, X-17) | Wuyi Aichi Industry and Trade Co., Ltd. | Apr 22, 2026 | SESE |
| [K252813](/device/K252813.md) | Electrical Scooter (SM4226) | Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd. | Mar 17, 2026 | SESE |
| [K253936](/device/K253936.md) | Power Mobility Scooter (MJMA01, MJMA02) | Nanjing Mijo Technology Co., Ltd. | Mar 12, 2026 | SESE |
| [K253631](/device/K253631.md) | Mobility Scooter (CL-Q3, CL-Q4) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | Feb 23, 2026 | SESE |
| [K253643](/device/K253643.md) | Mobility Scooter (S3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | Feb 18, 2026 | SESE |
| [K252349](/device/K252349.md) | Electric Scooter (Mojo-T330) | Dongguan Smarfody Mobility Technology Co., Ltd. | Jan 29, 2026 | SESE |
| [K252347](/device/K252347.md) | Electric Scooter (Mojo-T580) | Dongguan Smarfody Mobility Technology Co., Ltd. | Jan 29, 2026 | SESE |
| [K252275](/device/K252275.md) | Electric Scooter (DDF100) | Zhejiang Nysin Medical Co., Ltd. | Jan 29, 2026 | SESE |
| [K253075](/device/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](/device/K252817.md) | Mobility Scooter (BC-MS310) | Ningbo Baichen Medical Devices Co., Ltd. | Jan 2, 2026 | SESE |
| [K252835](/device/K252835.md) | Electric Scooter (S202572J, S2060, M2089, S2050) | Guangdong Prestige Technology Co., Ltd. | Dec 23, 2025 | SESE |
| [K252588](/device/K252588.md) | Mobility Scooter (T5) | Zhejiang Taotao Vehicle Co., Ltd. | Dec 4, 2025 | SESE |
| [K252590](/device/K252590.md) | Powered Mobility Scooter  (PMS105, GUT177, GCAT047) | Intradin (Shanghai) Machinery Co., Ltd. | Nov 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
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd — 11 clearances

---

**Source:** [https://fda-staging.innolitics.com/productcode/INI](https://fda-staging.innolitics.com/productcode/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