K222669 is an FDA 510(k) clearance for the Cryopush Cold Compression Device. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Chengdu Cryo-Push Medical Technology Co.,Ltd (Chengdu, CN). The FDA issued a Cleared decision on December 5, 2022, 90 days after receiving the submission on September 6, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K222669 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2022 |
| Decision Date | December 05, 2022 |
| Days to Decision | 90 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 |