FDA device listing
AUVON, Anti-Slip Wheelchair Cushions, model SW4111,AUVON, Cooling Gel Wheelchair Seat Cushion, model SW6652,AUVON, Gel…
FDA device listing 2041735653 · UAN HEALTHCARE LIMITED
Key facts
| Proprietary names | AUVON, Anti-Slip Wheelchair Cushions, model SW4111,AUVON, Cooling Gel Wheelchair Seat Cushion, model SW6652,AUVON, Gel seat cushion, model SO7682,AUVON, Gel seat cushion, model SW1651,AUVON, Gel Wheelchair Donut Pillow, model SW6651,AUVON, Wheelchair Donut Pillow, model SW6111,AUVON, Wheelchair Seat Cushions, model SC1111 |
|---|---|
| Owner/operator | UAN HEALTHCARE LIMITED |
| Owner/operator number | 10094761 |
| Product codes | FMP |
| Device names | FMP - Protector, Skin Pressure |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6450 |
| Review panels | General Hospital |
| Registered establishments | UAN Healthcare Limited |
| Establishment registrations | 3043013796 |
| FEI numbers | 3043013796 |
| Establishment operations | Foreign Private Label Distributor |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database