K230524 is an FDA 510(k) clearance for the Cold Compression Wrap Pro. 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 January 19, 2024, 326 days after receiving the submission on February 27, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K230524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2023 |
| Decision Date | January 19, 2024 |
| Days to Decision | 326 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 |