Mobility Scooter W3331F
by Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
510(k) K222495
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222495 | Date17 Oct 2022 | StatusActive |
Official records
- FDA 510(k) database K222495
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Mobility Scooter, Model: W3331F
- 510(k) Number
- FDA product code
- INI
- FDA applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
- Device class
- Class II
- Regulation
- 21 CFR Part 890.3800
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Mobility Scooter W3331F is a motorized three-wheeled vehicle designed for individuals with limited mobility. It assists users in indoor and outdoor environments by providing powered propulsion, enabling independent movement over short to moderate distances. The device is classified as a Class II medical device under FDA regulations, intended for personal transport and mobility support.
This mobility scooter is supplied as a reusable device, intended for long-term use by individuals requiring assistance with ambulation. It is not sterile and is not intended for MRI environments. The W3331F model is regulated under 21 CFR 890.3800 and received FDA 510(k) clearance (K222495) as substantially equivalent to predicate devices. Storage and maintenance instructions are provided by the manufacturer to ensure safe and effective operation.
Devices cleared under K222495
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Mobility Scooter W3331F | W3331F | 06978949462798 | — | On the market |
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