Recall Z-0205-2018— Won Industry Co.

Name: FDA recall Z-0205-2018
Creator: U.S. Food and Drug Administration
Published: 2017-01-13

Class II · Terminated

Class II FDA medical device recall by Won Industry Co., initiated 2017-01-13, terminated 2023-05-24. It names one FDA 510(k) clearance: K120166. 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: Distribution of unapproved devices with incorrect air compression level setup.

Recalling firm: Won Industry Co.
Classification: Class II
Status: Terminated
Initiated: 2017-01-13
Terminated: 2023-05-24
Firm location: Siheung-si, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K120166 — COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEMWon Industrial Co.·cleared 2012-05-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.