Data / Medical devices / Germany / Bauerfeind AG
Bauerfeind AG: FDA-registered device maker in ZEULENRODA-TRIEBES Thuringia, Germany, 2 510(k) clearances
Bauerfeind AG is registered with the FDA (registration 8010507) in ZEULENRODA-TRIEBES Thuringia, Germany. It lists 14 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 4, 2011. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 8010507
- FEI number
- 3005091242
- Address
- Triebeser Strasse 16, ZEULENRODA-TRIEBES Thuringia, Germany, 07937
- Owner or operator
- BAUERFEIND AG (8010507)
- Roles
- Manufacturer
- First device listed
- October 24, 2001
- Registered through
- 2026
- Brand names listed
- AchilloTrain, AchilloTrain Pro, AirLoc,, CaligaLoc, CerviLoc, CerviLoc S, Cervical Orthoses, Corrective Shoe, and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Transfer | IKX | 1 | Manufacturer | accessdata.fda.gov |
| Device, Prosthesis Alignment | IQO | 1 | Manufacturer | accessdata.fda.gov |
| Joint, Ankle, External Brace | ITW | 1 | Manufacturer | accessdata.fda.gov |
| Joint, Hip, External Brace | ITS | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical | IQK | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Corrective Shoe | KNP | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbar | IQE | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Sacroiliac, Soft | IPW | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Manufacturer | accessdata.fda.gov |
| Sling, Arm | ILI | 1 | Manufacturer | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Manufacturer | accessdata.fda.gov |
| Support, Arm | IOY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 4, 2011 | K111662 | VENOTRAIN CURAFLOW | DWL | Substantially Equivalent | Bauerfeind AG | accessdata.fda.gov |
| June 18, 1986 | K860826 | VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE | DWL | Substantially Equivalent | Bauerfeind GmbH & Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Corrective Shoe
- All makers of Support, Arm
- All makers of Orthosis, Cervical
- All makers of Orthosis, Limb Brace
- All makers of Joint, Hip, External Brace
- All makers of Joint, Ankle, External Brace
Updated October 4, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.