K210979 is an FDA 510(k) clearance for the Prelivia. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Rehabtronics, Inc. (Edmonton, CA). The FDA issued a Cleared decision on May 13, 2021, 42 days after receiving the submission on April 1, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K210979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2021 |
| Decision Date | May 13, 2021 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |