K242140 is an FDA 510(k) clearance for the Air Compression Leg Massager (K-705). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Jiale Health Technology Shenzhen Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 17, 2025, 238 days after receiving the submission on July 22, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K242140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2024 |
| Decision Date | March 17, 2025 |
| Days to Decision | 238 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 |