FDA device listing
Doc Ortho abdominal binder,Doc Ortho hernia support belt,Doc Ortho lumbar sacral support,Doc Ortho lumbostyle back…
FDA device listing 1680185263 · MEDI BAYREUTH
Key facts
| Proprietary names | Doc Ortho abdominal binder,Doc Ortho hernia support belt,Doc Ortho lumbar sacral support,Doc Ortho lumbostyle back support,Doc Ortho maternity belt,Lumbamed basic,Lumbamed facet,Lumbamed plus,Lumbamed plus E+motion,Lumbamed sacro,Lumbamed stabil,medi Lumbar 627,medi Lumbar 631,medi Lumbar 637,medi Posture plus force,medi Posture plus pants,protect abdominal binder,protect.hernia… |
|---|---|
| Owner/operator | MEDI BAYREUTH |
| Owner/operator number | 8010822 |
| Product codes | IQE |
| Device names | IQE - Orthosis, Lumbar |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| 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