The following data is part of a premarket notification filed by Timewaver Production Gmbh with the FDA for Timewaver Frequency.
| Device ID | K212832 |
| 510k Number | K212832 |
| Device Name: | TimeWaver Frequency |
| Classification | Stimulator, Muscle, Powered |
| Applicant | TimeWaver Production GmbH Schloss Kraenzlin, Darritzer Strass 6 Kraenzlin, DE 16818 |
| Contact | Babak Jafarian |
| Correspondent | Douglas Herrington Herrington Consulting LLC 2885 Sanford Ave SW 43083 Grandville, MI 49418 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-07 |
| Decision Date | 2021-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251784202067 | K212832 | 000 |