510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K100521Substantially Equivalent

Comfysleeve 1-75 and Lymphapod Sleeves, for Use with Lp Optimal and Plus

MEGO AFEK AC Ltd., Kfar Saba, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100521 is the FDA 510(k) clearance record for COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS, a class II device, cleared for Mego Afek AC , Ltd. on under FDA product code JOW (Sleeve, Limb, Compressible). FDA records list 17 510(k) clearances for Mego Afek AC , Ltd., from to . As of , FDA records show no recalls naming K100521.

Clearance record

Decision date
Received
(80 days to decision)
Product code
JOW Sleeve, Limb, Compressible
Regulation
21 CFR 870.5800
Device class
Class II
Review panel
Cardiovascular
Applicant
Mego Afek AC , Ltd. 20 Hata'As St., Kfar Saba, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOW

Trailing 12 months
8 clearances under product code JOW in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code JOW, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20261
July 20261
August 20261
September 20261
October 20260