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Lympha Press Optimal, Model 1201AP

by Mego Afek AC, Ltd. 510(k)

Active United States

510(k) K082149

Overview

The Lympha Press Optimal, Model 1201AP is a Sleeve, Limb, Compressible device designed for pneumatic compression therapy. It applies sequential air pressure to a compression garment worn around a limb, promoting lymphatic drainage and venous return to manage chronic lymphedema and vascular disorders.

This device is supplied as a reusable pneumatic compression system with a software-controlled air pump. It operates in a clinical or home-care setting, adhering to FDA 510(k) clearance (K082149) under the Cardiovascular advisory committee. The device is intended for single-patient use with proper sterilization between applications. No MRI safety information is specified, and it is classified as a Class II medical device under regulation 870.5800.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082149 Date6 Oct 2008ClearedStatusActive

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 is the Lympha Press Optimal 1201AP designed for?

    The Lympha Press Optimal 1201AP is a pneumatic compression sleeve designed specifically for pneumatic compression therapy. It applies sequential air pressure to a compression garment worn around a limb to promote lymphatic drainage and improve venous return. This helps manage chronic conditions like lymphedema and vascular disorders by enhancing circulation in the affected area.

  • How is the Lympha Press Optimal 1201AP supplied and intended for use?

    The device is supplied as a reusable pneumatic compression system, which includes a software-controlled air pump. It is intended for use in both clinical and home-care settings. The system is designed for single-patient use, meaning it must be properly sterilized between applications to ensure safety and hygiene.

  • Is the Lympha Press Optimal 1201AP single-use or reusable?

    The Lympha Press Optimal 1201AP itself is a reusable pneumatic compression system. However, it is intended for single-patient use, requiring sterilization between applications to maintain cleanliness and prevent cross-contamination. This ensures the device remains safe and effective for its intended purpose.

  • What regulatory clearance does the Lympha Press Optimal 1201AP hold?

    The Lympha Press Optimal 1201AP holds FDA 510(k) clearance under the Cardiovascular advisory committee. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for safety and effectiveness in its intended use for pneumatic compression therapy.

  • What are the key specifications or features of the Lympha Press Optimal 1201AP?

    The device is classified as a Class II medical device under regulation 870.5800. It operates using a software-controlled air pump to deliver sequential air pressure to compression garments worn on limbs. The system is designed to be versatile, suitable for both clinical and home-care environments, and supports the management of chronic conditions such as lymphedema and vascular disorders.