Data / Medical devices / Germany / Otto Bock Manufacturing Konigsee GmbH
Otto Bock Manufacturing Konigsee GmbH: FDA-registered device maker in Koenigsee Thuringia, Germany, 1 510(k) clearance
Otto Bock Manufacturing Konigsee GmbH is registered with the FDA (registration 9681725) in Koenigsee Thuringia, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 7, 2006. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9681725
- FEI number
- 1000413464
- Address
- Lindenstrasse 13, Koenigsee Thuringia, Germany, D-07426
- Owner or operator
- Ottobock SE & Co. KGaA (8010097)
- Roles
- Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 10, 2000
- Registered through
- 2026
- Brand names listed
- Paragolfer, Various models
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wheelchair, Standup | IPL | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| August 7, 2006 | K060936 | PARAGOLFER | IPL | Substantially Equivalent | Parabasetec, GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Components, Wheelchair
- All makers of Accessories, Wheelchair
- All makers of Wheelchair, Standup
Updated August 7, 2006. 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.