K251531 is an FDA 510(k) clearance for the AIR COMPRESSION BOOTS 1018195,1018196. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Merchsource, LLC (Irvine, US). The FDA issued a Cleared decision on October 30, 2025, 164 days after receiving the submission on May 19, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K251531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2025 |
| Decision Date | October 30, 2025 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |