FDA device listing
Adapt Air,Adapt Air Pro,Adapt Convertible,Alternate,Alternating Pressure Air Flotation Overlay Systems,Alternating…
FDA device listing 1196659677 · RAYE'S, Inc dba Sizewise Manufacturing a wholly owned subsid
Key facts
| Proprietary names | Adapt Air,Adapt Air Pro,Adapt Convertible,Alternate,Alternating Pressure Air Flotation Overlay Systems,Alternating Pressure Air Flotation Systems,Capillaire Crib ™,Capillaire OR ™,Capillaire OR Lithotomy ™,Capillaire OR Pedi ™,Capillaire SS ™,Capillaire ST ™,Dabir Patient Care Plus,Dabir Surgical System,Mighty Air,NPT3,NPT4,Platinum 6000 |
|---|---|
| Owner/operator | RAYE'S, Inc dba Sizewise Manufacturing a wholly owned subsid |
| Owner/operator number | 1931307 |
| Product codes | FNM |
| Device names | FNM - Mattress, Air Flotation, Alternating Pressure |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5550 |
| Review panels | General Hospital |
| Registered establishments | Agiliti Health - Corona, Agiliti Health - Ellis, Agiliti Health - Hays, Agiliti Health - Milwaukee, RASMUSSEN DE TECATE S.A. DE C.V. |
| Establishment registrations | 1931307, 1954156, 2030732, 3029836575, 3034243939 |
| FEI numbers | 1931307, 3000204953, 3002693132, 3029836575, 3034243939 |
| Establishment operations | Complaint File Establishment, Manufacturer, Contract Manufacturer, Repackager/Relabeler, 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