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

by Mego Afek AC, Ltd. 510(k)

Active United States

510(k) K100521

Overview

The Comfysleeve 1-75 and Lymphapod Sleeves are compressible limb sleeves designed for use with the LP Optimal and Plus systems. These devices function as part of a compression therapy system that utilizes a software-controlled air pump to sequentially inflate garment cells, which moves interstitial fluid into the venous and lymphatic systems to improve limb circulation.

These sleeves are intended for use in home, clinic, or hospital settings by patients or clinicians. The device is authorized under FDA 510(k) number K100521.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100521 Date14 May 2010ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
JOW
FDA applicant
Mego Afek AC , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.5800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What are the Comfysleeve 1-75 and Lymphapod Sleeves used for?

    These sleeves are designed to function as part of a compression therapy system. They use a software-controlled air pump to sequentially inflate garment cells, which helps move interstitial fluid into the venous and lymphatic systems to improve limb circulation.

  • Where can these compression sleeves be used?

    The sleeves are intended for use in home, clinic, or hospital settings, allowing them to be utilized by either patients or clinicians depending on the care environment.

  • Which systems are these sleeves compatible with?

    The Comfysleeve 1-75 and Lymphapod Sleeves are specifically designed for use with the LP Optimal and Plus compression therapy systems.