K221862 is an FDA 510(k) clearance for the YY-A02-B Overlapped Compression Therapy. 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 December 8, 2022, 164 days after receiving the submission on June 27, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K221862 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 27, 2022 |
| Decision Date | December 08, 2022 |
| Days to Decision | 164 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 |