K131309 is an FDA 510(k) clearance for the SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ. This device is classified as a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMI).
Submitted by Ibramed Equipamentos Medicos (Aventura, US). The FDA issued a Cleared decision on January 27, 2014, 265 days after receiving the submission on May 7, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300.
| 510(k) Number | K131309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2013 |
| Decision Date | January 27, 2014 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMI - Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5300 |