K243488 is an FDA 510(k) clearance for the VMAT PRO. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Termosalud (Gijon, ES). The FDA issued a Cleared decision on February 6, 2025, 86 days after receiving the submission on November 12, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K243488 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2024 |
| Decision Date | February 06, 2025 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISA - Massager, Therapeutic, Electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5660 |