FDAFDA · Food and drugs·Recall number Z-0205-2018
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.
Published December 13, 2017 · Recall initiated: January 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Distribution of unapproved devices with incorrect air compression level setup
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Won Industry Co.
- Distributor
- Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
- Lot
- none
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Korea (the Republic of)
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