K251662 is an FDA 510(k) clearance for the Air Compression Therapy Device (ST-504). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Shenzhen Future Electronic Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 13, 2025, 167 days after receiving the submission on May 30, 2025.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K251662 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 2025 |
| Decision Date | November 13, 2025 |
| Days to Decision | 167 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 |