K202788 is an FDA 510(k) clearance for the Sonomed IV, Sonomed V. This device is classified as a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMI).
Submitted by Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto (Sao Paulo, BR). The FDA issued a Cleared decision on December 23, 2021, 457 days after receiving the submission on September 22, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300.
| 510(k) Number | K202788 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2020 |
| Decision Date | December 23, 2021 |
| Days to Decision | 457 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 |