FDA device listing
Doc Ortho carpal tunnel support,Doc Ortho CF premium wrist brace,Doc Ortho epi elbow support,Doc Ortho Foot Support…
FDA device listing 1218392045 · MEDI BAYREUTH
Key facts
| Proprietary names | Doc Ortho carpal tunnel support,Doc Ortho CF premium wrist brace,Doc Ortho epi elbow support,Doc Ortho Foot Support Active,Doc Ortho Foot Support Ballerinas Pro,Doc Ortho Foot Support Business,Doc Ortho Foot Support Business Pro,Doc Ortho Foot Support Business Slim Pro,Doc Ortho Foot Support Comfort,Doc Ortho Foot Support Comfort Pro,Doc Ortho Foot Support Control,Doc Ortho Foot Support Gentlemen… |
|---|---|
| Owner/operator | MEDI BAYREUTH |
| Owner/operator number | 8010822 |
| Product codes | IQI |
| Device names | IQI - Orthosis, Limb Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | MEDI BAYREUTH, MEDI MFG., INC. |
| Establishment registrations | 1063312, 8010822 |
| FEI numbers | 4599, 3000719631 |
| Establishment operations | Manufacturer, Specification Developer, 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