Won Industry Co. recalls Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended f…

Recall date

January 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0205-2018

FDA classification

Class II

Brand / firm

Won Industry Co.

Sold / distributed

Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico

Why it was recalled

Distribution of unapproved devices with incorrect air compression level setup

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in cardiovascular and to relax stressed muscle by increasing the temperature of hypodermic tissue and expanding the blood vessels. It vitalizes the circulation of blood and lymph in arms, legs and waist and enhances the pressure of muscular issues to remove swelling or pain.