K182003 is an FDA 510(k) clearance for the Lympha Press Optimal Plus. This device is classified as a Sleeve, Limb, Compressible (Class II - Special Controls, product code JOW).
Submitted by Mego Afek AC , Ltd. (Kibbutz Afek, IL). The FDA issued a Cleared decision on February 27, 2019, 216 days after receiving the submission on July 26, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K182003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2018 |
| Decision Date | February 27, 2019 |
| Days to Decision | 216 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 |