FDA Recall Terminated

Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 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.

Recall: Z-0204-2018 · Initiated January 13, 2017

Recall

Recall Number
Z-0204-2018
Event Number
78182
Firm
Won Industry Co. 7-12 Bangadari-Gil Siheung-si Korea (the Republic of)
FEI Number
3005515255
Product Code
IRP
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
January 13, 2017
Terminated
May 24, 2023

Description

Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 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

Action

Beginning on January 13, 2017, Won Industry Co., Ltd. distributed a Recall Request notices to their customers via email advising customers to retrieve the devices subject to recall.

Distribution

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

Quantity

2