FDA device listing
Foam Abduction Pillows,Foam Arm/Elbow/Ulnar Protectors,Foam Bolsters/Extenders, Siderails,Foam Donuts,Foam…
FDA device listing 1253297315 · JOERNS HEALTHCARE LLC
Key facts
| Proprietary names | Foam Abduction Pillows,Foam Arm/Elbow/Ulnar Protectors,Foam Bolsters/Extenders, Siderails,Foam Donuts,Foam Headcradles,Foam Heel/Ankle/Foot protectors,Foam Pillows,Foam Wedges/Aligners |
|---|---|
| Owner/operator | JOERNS HEALTHCARE LLC |
| Owner/operator number | 9105099 |
| 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 | Joerns Healthcare |
| Establishment registrations | 3009402404, 3012392312 |
| FEI numbers | 3009402404, 3012392312 |
| Establishment operations | Complaint File Establishment, 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