FDA Enforcement Class II 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 · Reported December 13, 2017

Enforcement

Recall Number
Z-0204-2018
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

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

Code Info

Serial numbers: EMM16100968 and EMM16100967 MFG DATE: 2016.10.10

Distribution

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

Quantity

2