K131926 is an FDA 510(k) clearance for the THERMOPULSE. This device is classified as a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMJ).
Submitted by Ibramed Equipamentos Medicos (Aventura, US). The FDA issued a Cleared decision on July 24, 2014, 393 days after receiving the submission on June 26, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K131926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2013 |
| Decision Date | July 24, 2014 |
| Days to Decision | 393 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | - |
| Product Code | IMJ - Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |