UDI device identifier
Xtreme X8 4WD Xtreme X8
UDI device identifier 00016958059694 · SUNRISE MEDICAL (US) LLC
Key facts
| Primary DI | 00016958059694 |
|---|---|
| Brand name | Xtreme X8 4WD |
| Version or model | Xtreme X8 |
| Catalog number | EIMM |
| Company | SUNRISE MEDICAL (US) LLC |
| DUNS number | 962525056 |
| Product code | ITI |
| GMDN term | Wheelchair recliner, battery-powered |
| Premarket submission | K211574 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 12, 2023 |
| Version date | May 20, 2025 |
| 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. |
At a glance
- 1–9 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: