K222991 is an FDA 510(k) clearance for the Air Compression Leg Massager (model: EMK-701). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Xiamen Emoka Health Science & Technology Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on March 15, 2023, 168 days after receiving the submission on September 28, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K222991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2022 |
| Decision Date | March 15, 2023 |
| Days to Decision | 168 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 |