FDA device listing
Foot and Leg Stabalizer Wedge,Prevalon AirTAP XXL Patient Repositioning System Wedges,Prevalon Heel Protectors I, II…
FDA device listing 2041143447 · SAGE PRODUCTS LLC
Key facts
| Proprietary names | Foot and Leg Stabalizer Wedge,Prevalon AirTAP XXL Patient Repositioning System Wedges,Prevalon Heel Protectors I, II, III,Prevalon TAP XL Turn and Position System Wedges,Prevalon TAP XXL Turn and Position System Wedges,Prevalon Turn and Position System 1.0 (TAP 1.0) Wedges,Prevalon Turn and Position System 2.0 (TAP 2.0) Wedges (30 degree body wedges with anchor wedge),Sage Basic Positioning Wedges |
|---|---|
| Owner/operator | SAGE PRODUCTS LLC |
| Owner/operator number | 9914017 |
| 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 | SAGE PRODUCTS LLC |
| Establishment registrations | 1419181 |
| FEI numbers | 1419181 |
| 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