Identity
- Trade Name
- Xtreme X8 4WD FDA UDI
- Generic Name
- Wheelchair recliner, battery-powered FDA UDI
- Device Name
- Through sand or snow and up or down curbs, the Extreme X8 is a true all-terrain power wheelchair. Unrivaled 4x4 off-road performance and reliability make it the perfect outdoor wheelchair for adventurers, explorers, and rural workers alike. FDA UDI
- Model / Reference
- Xtreme X8 FDA UDI
- Description
- Through sand or snow and up or down curbs, the Extreme X8 is a true all-terrain power wheelchair. Unrivaled 4x4 off-road performance and reliability make it the perfect outdoor wheelchair for adventurers, explorers, and rural workers alike. FDA UDI
Identifiers
- Catalog Number
- EIMM FDA UDI
- Primary DI / UDI-DI
- 00016958059694 FDA UDI
- 510(k) Number
- K211574 FDA UDI
- FDA Product Code
- ITI FDA UDI
- GMDN Term
- Wheelchair recliner, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wheelchair recliner, battery-powered
Xtreme X8 4WD by Sunrise Medical (US) LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
Sources (1)
- FDA UDI b348f742-e809-4131-978a-0a64fe3888d2 35 fields · synced Jun 9, 2026