Xtreme X8 4WD
Xtreme X8 4WD (EIMM) is a wheelchair recliner (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Sunrise Medical (US) LLC, cleared under FDA 510(k) K211574 on 9 Jul 2021 and listed in FDA GUDID since 12 Sep 2023 (UDI-DI 00016958059694), 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 | Number00016958059694 | Date12 Sep 2023 | StatusListed |
| United States | FDA 510(k) | NumberK211574 | Date9 Jul 2021 | StatusActive |
Official records
- AccessGUDID record 00016958059694
- FDA 510(k) database K211574
Across registries
- FDA 510(k) K211574 decided 9 Jul 2021 Active
- FDA GUDID UDI-DI 00016958059694 listed 12 Sep 2023 Listed
Timeline
- Cleared FDA 510(k) K211574
- Listed FDA GUDID 00016958059694
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Wheelchair recliner, battery-powered
- Model / Ref / Catalog
- Xtreme X8, EIMM
- Primary DI / UDI-DI
- 00016958059694
- 510(k) Number
- FDA product code
- ITI
- GMDN term
- Wheelchair recliner, battery-powered
- Device class
- Class II
- Regulation number
- 890.3860
- GUDID distribution status
- In Commercial Distribution
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