K214053 is an FDA 510(k) clearance for the Amputee Garment for use with 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. (Kibbuts Afek, IL). The FDA issued a Cleared decision on April 14, 2022, 108 days after receiving the submission on December 27, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5800.
| 510(k) Number | K214053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 27, 2021 |
| Decision Date | April 14, 2022 |
| Days to Decision | 108 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 |