FDA device listing
b:joynz knee brace,b:joynz knee brace pro,b:joynz knee immobilizer 0,b:joynz knee immobilizer 20,b:joynz knee ROM
FDA device listing 1988859678 · Bauerfeind USA
Key facts
| Proprietary names | b:joynz knee brace,b:joynz knee brace pro,b:joynz knee immobilizer 0,b:joynz knee immobilizer 20,b:joynz knee ROM |
|---|---|
| Owner/operator | Bauerfeind USA |
| Owner/operator number | 10029793 |
| Product codes | ITQ |
| Device names | ITQ - Joint, Knee, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | Bauerfeind USA, INC. |
| Establishment registrations | 1037964 |
| FEI numbers | 1037964 |
| 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