FDA device listing
b:joynz back support straight,b:joynz back support waisted,DorsoTrain,LordoLoc,LordoLoc ES,LumboLoc,LumboLoc ES,LumboLoc…
FDA device listing 1337525160 · BAUERFEIND AG
Key facts
| Proprietary names | b:joynz back support straight,b:joynz back support waisted,DorsoTrain,LordoLoc,LordoLoc ES,LumboLoc,LumboLoc ES,LumboLoc Forte,LumboLoc Forte ES,LumboLoc Forte SP,LumboLoc Forte XT,Lumbo Plus,LumboTrain,LumboTrain ES,LumboTrain Lady,LumboTrain straight,LumboTrain waisted,SecuTec Dorso,SecuTec Lumbo,SofTec Dorso,SofTec Lumbo,Spinova Immo,Sports Back Support |
|---|---|
| Owner/operator | BAUERFEIND AG |
| Owner/operator number | 8010507 |
| Product codes | IQE |
| Device names | IQE - Orthosis, Lumbar |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | BAUERFEIND AG |
| Establishment registrations | 8010507 |
| FEI numbers | 3005091242 |
| Establishment operations | Manufacturer |
| 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