K121962 is an FDA 510(k) clearance for the PRACTICAL COMPRESSION DEVICE (PCD) 901A&901B. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Mego Afek AC , Ltd. (Afek, IL). The FDA issued a Cleared decision on October 19, 2012, 106 days after receiving the submission on July 5, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K121962 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2012 |
| Decision Date | October 19, 2012 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | JOW - Sleeve, Limb, Compressible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5800 |