Home / Recalls / Medical Devices
Won Industry Co. recalls Compressible Limb Therapy System (Leg Cuffs, Arm Sleeves, Waist pads and air injection hoses) Product Usage: Intende
Recalled December 13, 2017 · FDA recall Z-0205-2018 · Won Industry
Hazard
Distribution of unapproved devices with incorrect air compression level setup · FDA Class II
Units
3
Sold at
Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Description
Distribution of unapproved devices with incorrect air compression level setup
Product
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.
Manufacturer(s)
Won Industry Co.
Made in
Korea (the Republic of)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →