K221654 is an FDA 510(k) clearance for the medi pneumatic compression system (pcs)-genius (Model 652). This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Medi USA, LP (Whitsett, US). The FDA issued a Cleared decision on July 7, 2022, 30 days after receiving the submission on June 7, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K221654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2022 |
| Decision Date | July 07, 2022 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |