K060220 is an FDA 510(k) clearance for the PBS MODEL 701A COMPRESSION THERAPY DEVICE. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Mego Afek (Kfar Saba, IL). The FDA issued a Cleared decision on February 9, 2006, 10 days after receiving the submission on January 30, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K060220 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2006 |
| Decision Date | February 09, 2006 |
| Days to Decision | 10 days |
| Submission Type | Special |
| 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 |