Mego Afek , Ltd. - FDA 510(k) Cleared Devices

Mego Afek, Ltd. is an Israeli medical device manufacturer specializing in pneumatic compression therapy systems. Founded in the mid-1960s at Kibbutz Afek in northern Israel, the company develops and produces dynamic compression devices for circulatory enhancement and therapeutic applications.

The company has received 1 FDA 510(k) clearance from 1 total submission. Mego Afek focuses exclusively on Cardiovascular devices, with its latest FDA clearance in 2026. The company maintains active regulatory status and holds quality certifications including ISO 13485:2016 and compliance with CFR 820.

Mego Afek's product portfolio includes systems for lymphedema and venous insufficiency treatment, deep vein thrombosis prevention, and aesthetic compression solutions. The company's devices are marketed internationally under brand names including Lympha Press®, Phlebo Press®, and Ballancer®. Products have received regulatory approvals from FDA, CE Mark, MHLW (Japan), and ANVISA (Brazil).

Explore the company's cleared device names, product codes, and clearance dates in the database above.

510(k) submissions have been managed by Ilan Sharon MD Consultant as regulatory consultant.