UDI device identifier
Empluse F35
UDI device identifier 00016958059380 · SUNRISE MEDICAL (US) LLC
Key facts
| Primary DI | 00016958059380 |
|---|---|
| Brand name | Empluse |
| Version or model | F35 |
| Catalog number | EISP11 |
| Company | SUNRISE MEDICAL (US) LLC |
| DUNS number | 962525056 |
| Product code | ITI |
| GMDN term | Wheelchair electric-motor-driven propulsion system |
| Premarket submission | K220213 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Apr 21, 2025 |
| Version date | May 20, 2025 |
| Description | A wheelchair power assist device. It uses a lithium battery to power a single front wheel, which the handlebar can steer. The device is attached to the wheelchair by a hook-and-latched subframe and a permanently installed wheelchair frame clamp. |
At a glance
- None 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: