K212832 is an FDA 510(k) clearance for the TimeWaver Frequency. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Timewaver Production GmbH (Kraenzlin, DE). The FDA issued a Cleared decision on December 14, 2021, 98 days after receiving the submission on September 7, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K212832 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2021 |
| Decision Date | December 14, 2021 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |