FDA recall Z-0205-2018

Won Industry Co. · Class II · device

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.

Reason for recall

Distribution of unapproved devices with incorrect air compression level setup

Distribution

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

Key facts

Status
Terminated
Initiation date
2017-01-13
Report date
2017-12-13
Termination date
2023-05-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Siheung-si, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2018