FDA device listing
Formfit Pro Elbow,Formfit Tennis Elbow,Rebound Post-Op Elbow,Tennis Elbow Support with Hot/Cold Therapy Gel Pad
FDA device listing 1477262984 · OSSUR Americas
Key facts
| Proprietary names | Formfit Pro Elbow,Formfit Tennis Elbow,Rebound Post-Op Elbow,Tennis Elbow Support with Hot/Cold Therapy Gel Pad |
|---|---|
| Owner/operator | OSSUR Americas |
| Owner/operator number | 9026971 |
| Product codes | IOY |
| Device names | IOY - Support, Arm |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | OSSUR AMERICAS, OSSUR EUROPE B.V., Ossur Iceland ehf. |
| Establishment registrations | 2242474, 3003764610, 3004161950 |
| FEI numbers | 2242474, 3003764610, 3004161950 |
| Establishment operations | Complaint File Establishment, Specification Developer, Foreign Exporter, Repackager/Relabeler |
| 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