K251623 is an FDA 510(k) clearance for the Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Shenzhen Yicai Health Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 17, 2025, 112 days after receiving the submission on May 28, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K251623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2025 |
| Decision Date | September 17, 2025 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | IRP - Massager, Powered Inflatable Tube |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5650 |