K100521 is an FDA 510(k) clearance for the COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Mego Afek AC , Ltd. (Kfar Saba, IL). The FDA issued a Cleared decision on May 14, 2010, 80 days after receiving the submission on February 23, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K100521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2010 |
| Decision Date | May 14, 2010 |
| Days to Decision | 80 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 |