Xsto M4U
Xsto M4U is an electric-motor-driven wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Xsto Co., Ltd., cleared under FDA 510(k) K242358 on 3 Apr 2025 and listed in FDA GUDID since 16 Jun 2025 (UDI-DI 06975052650128), active as of 22 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 | Number06975052650128 | Date16 Jun 2025 | StatusListed |
| United States | FDA 510(k) | NumberK242358 | Date3 Apr 2025 | StatusActive |
Official records
- AccessGUDID record 06975052650128
- FDA 510(k) database K242358
Across registries
- FDA 510(k) K242358 decided 3 Apr 2025 Active
- FDA GUDID UDI-DI 06975052650128 listed 16 Jun 2025 Listed
Timeline
- Cleared FDA 510(k) K242358
- Listed FDA GUDID 06975052650128
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Xsto
- Generic name
- Electric-motor-driven wheelchair, occupant-controlled
- Model / reference
- M4U
- Primary DI / UDI-DI
- 06975052650128
- 510(k) Number
- FDA product code
- ITI
- GMDN term
- Electric-motor-driven wheelchair, occupant-controlled
- Device class
- Class II
- Regulation number
- 890.3860
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
Similar devices in this category
Other devices filed under Electric-motor-driven wheelchair, occupant-controlled.