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.
Enforcement
- Recall Number
- Z-0205-2018
- Event ID
- 78182
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Won Industry Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- December 13, 2017
- Initiation Date
- January 13, 2017
- Classification Date
- December 6, 2017
- Termination Date
- May 24, 2023
- Address
- 7-12 Bangadari-Gil, N/A, Siheung-si, N/A, N/A, Korea (the Republic of)
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.
Distribution of unapproved devices with incorrect air compression level setup
none
Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
3