FDA device listing
Sammons Preston All Purpose Boot,Sammons Preston Forefoot Offloading Shoe,Sammons Preston Heel Offloading Shoe
FDA device listing 1545372661 · Performance Health Supply
Key facts
| Proprietary names | Sammons Preston All Purpose Boot,Sammons Preston Forefoot Offloading Shoe,Sammons Preston Heel Offloading Shoe |
|---|---|
| Owner/operator | Performance Health Supply |
| Owner/operator number | 10050734 |
| Product codes | KNP |
| Device names | KNP - Orthosis, Corrective Shoe |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | PERFORMANCE HEALTH SUPPLY, LLC. |
| Establishment registrations | 2128677 |
| FEI numbers | 2128677 |
| Establishment operations | 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