K240981 is an FDA 510(k) clearance for the Air compression leg massager. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Huizhou Xinyi Technology Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on August 2, 2024, 114 days after receiving the submission on April 10, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K240981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2024 |
| Decision Date | August 02, 2024 |
| Days to Decision | 114 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 |