K131979 is an FDA 510(k) clearance for the PROVANT THERAPY SYSTEM. This device is classified as a Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (Class II - Special Controls, product code ILX).
Submitted by Regenesis Biomedical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on December 13, 2013, 168 days after receiving the submission on June 28, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K131979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2013 |
| Decision Date | December 13, 2013 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILX - Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |