K223541 is an FDA 510(k) clearance for the Cold/Hot Compression. This device is classified as a Massager, Powered Inflatable Tube (Class II - Special Controls, product code IRP).
Submitted by Jkh Health Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 27, 2023, 336 days after receiving the submission on November 25, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K223541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2022 |
| Decision Date | October 27, 2023 |
| Days to Decision | 336 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 |