FDA device listing
Dermisplus Prevent,Repose Flex,Repose Foot Protector,Repose Foot Protector Plus,Repose Sole Protector,Repose Wedge
FDA device listing 1198469771 · Frontier Therapeutics Inc.
Key facts
| Proprietary names | Dermisplus Prevent,Repose Flex,Repose Foot Protector,Repose Foot Protector Plus,Repose Sole Protector,Repose Wedge |
|---|---|
| Owner/operator | Frontier Therapeutics Inc. |
| Owner/operator number | 10059719 |
| 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 | FRONTIER THERAPEUTICS INC. |
| Establishment registrations | 3015423385 |
| FEI numbers | 3015423385 |
| Establishment operations | Complaint File Establishment |
| 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