FDA device listing
Alliance,Bari-Rehab Bed,Essentia™,Mighty Rest Rehab Bed,Sizewise Advantage Bed,Sizewise Behavioral Health Bed,Sizewise…
FDA device listing 1225230414 · RAYE'S, Inc dba Sizewise Manufacturing a wholly owned subsid
Key facts
| Proprietary names | Alliance,Bari-Rehab Bed,Essentia™,Mighty Rest Rehab Bed,Sizewise Advantage Bed,Sizewise Behavioral Health Bed,Sizewise Evolution Bed,Sizewise Low Bed |
|---|---|
| Owner/operator | RAYE'S, Inc dba Sizewise Manufacturing a wholly owned subsid |
| Owner/operator number | 1931307 |
| Product codes | FNL |
| Device names | FNL - Bed, Ac-Powered Adjustable Hospital |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5100 |
| Review panels | General Hospital |
| Registered establishments | Agiliti Health - Ellis, Agiliti Health - Hays, Agiliti Health - Milwaukee |
| Establishment registrations | 1931307, 1954156, 3029836575 |
| FEI numbers | 1931307, 3002693132, 3029836575 |
| Establishment operations | Manufacturer, Specification Developer |
| 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