Mobility Scooter W3331F
by Zhejiang Innuovo Rehabilitation Devices Co., Ltd
Mobility Scooter W3331F is an assistive scooter (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Zhejiang Innuovo Rehabilitation Devices Co., Ltd, cleared under FDA 510(k) K222495 on 17 Oct 2022 and listed in FDA GUDID since 8 Sep 2025 (UDI-DI 06978949462798), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06978949462798 | Date8 Sep 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222495 | Date17 Oct 2022 | StatusActive |
Official records
- AccessGUDID record 06978949462798
- FDA 510(k) database K222495
Across registries
- FDA 510(k) K222495 decided 17 Oct 2022 Active
- FDA GUDID UDI-DI 06978949462798 listed 8 Sep 2025 Listed
Timeline
- Cleared FDA 510(k) K222495
- Listed FDA GUDID 06978949462798
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mobility Scooter
- Generic name
- Assistive scooter, electric-motor-driven
- Model / reference
- W3331F
- Primary DI / UDI-DI
- 06978949462798
- 510(k) Number
- FDA product code
- INI
- GMDN term
- Assistive scooter, electric-motor-driven
- Device class
- Class II
- Regulation number
- 890.3800
- GUDID distribution status
- In Commercial Distribution
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