Data / Medical devices / Germany / TimeWaver Production GMBH
TimeWaver Production GMBH: FDA-registered device maker in Kraenzlin Brandenburg, Germany, 2 510(k) clearances
TimeWaver Production GMBH is registered with the FDA (registration 3009411292) in Kraenzlin Brandenburg, Germany. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 14, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009411292
- Address
- Schloss Kraenzlin Darritzer Strasse 6, Kraenzlin Brandenburg, Germany, 16818
- Owner or operator
- TimeWaver Production GmbH (10040063)
- Roles
- Manufacturer
- First device listed
- January 17, 2020
- Registered through
- 2026
- Brand names listed
- HEALY, TimeWaver Frequency
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | 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 |
|---|---|---|---|---|---|---|
| December 14, 2021 | K212832 | TimeWaver Frequency | IPF | Substantially Equivalent | Timewaver Production GmbH | accessdata.fda.gov |
| November 22, 2019 | K191075 | Healy | NUH | Substantially Equivalent | Timewaver Production GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
Updated December 14, 2021. 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.