The following data is part of a premarket notification filed by Mego Afek Ac Ltd. with the FDA for Amputee Garment For Use With Lympha Press Optimal Plus.
| Device ID | K214053 |
| 510k Number | K214053 |
| Device Name: | Amputee Garment For Use With Lympha Press Optimal Plus |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Mego Afek AC Ltd. Kibbuts Afek Kibbuts Afek, IL 3004200 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon Ilan Sharon MD Consultant P.O. Box 4414(A109) Caesarea, IL 3088900 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-27 |
| Decision Date | 2022-04-14 |