Data / Medical devices / Germany / Ergoline GMBH
Ergoline GMBH: FDA-registered device maker in BITZ Baden-Wurttemberg, Germany, 1 510(k) clearance
Ergoline GMBH is registered with the FDA (registration 3005438755) in BITZ Baden-Wurttemberg, Germany. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005438755
- Address
- Lindenstr. 5, BITZ Baden-Wurttemberg, Germany, 72475
- Owner or operator
- ERGOLINE GMBH (9078941)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 2, 2010
- Registered through
- 2026
- Brand names listed
- ergocar PC/basic
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Exerciser, Measuring | ISD | 2 | Manufacturer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Manufacturer | accessdata.fda.gov |
| Treadmill, Powered | IOL | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| July 15, 2022 | K212883 | ers2 - ergoline Rehabilitation System | DRG | Substantially Equivalent | Ergoline GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Exerciser, Measuring
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Operating Room Accessories Table Tray
- All makers of Treadmill, Powered
Updated July 15, 2022. 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.