K233536 is an FDA 510(k) clearance for the Air Compression Recovery System. 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 December 16, 2023, 43 days after receiving the submission on November 3, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5650.
| 510(k) Number | K233536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2023 |
| Decision Date | December 16, 2023 |
| Days to Decision | 43 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 |