K222206 is an FDA 510(k) clearance for the Air Compression Leg Massager (Models: S9036C, S9036B and S9036A). This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Shenzhen Dongjilian Medical Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 30, 2022, 67 days after receiving the submission on July 25, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K222206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2022 |
| Decision Date | September 30, 2022 |
| Days to Decision | 67 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 |