Medical device recalls Moderate risk

Won Industry Co. recalls Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compr…

Recall date
January 13, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0204-2018
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

Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 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.

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