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.
Z-0205-2018
Product summary
- Firm
- Won Industry Co.
- Event
- Event 78182
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-0205-2018
Official wording
Reason: Distribution of unapproved devices with incorrect air compression level setup
Code information: none
Distribution pattern: Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Derived failure modes
-
Unknown
Distribution of unapproved devices with incorrect air compression level setup