K223464 is an FDA 510(k) clearance for the Leg and Foot Air Wave Pressure Therapy Device. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Zhangzhou Easepal Innovation CO , Ltd. (Zhangzhou, CN). The FDA issued a Cleared decision on March 14, 2023, 117 days after receiving the submission on November 17, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K223464 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2022 |
| Decision Date | March 14, 2023 |
| Days to Decision | 117 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 |