K240373 is an FDA 510(k) clearance for the Air compression Leg Massager (MM0520, MM0521, MM0522). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Zhangzhou Easepal Medical Science and Technology Co., Ltd. (Zhangzhou, CN). The FDA issued a Cleared decision on September 17, 2024, 223 days after receiving the submission on February 7, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K240373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2024 |
| Decision Date | September 17, 2024 |
| Days to Decision | 223 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 |