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U.S. Department of Health and Human Services

Class 2 Device Recall Morning Life

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 Class 2 Device Recall Morning Lifesee related information
Date Initiated by FirmJanuary 13, 2017
Create DateDecember 06, 2017
Recall Status1 Terminated 3 on May 24, 2023
Recall NumberZ-0204-2018
Recall Event ID 78182
510(K)NumberK120166 
Product Classification Massager, powered inflatable tube - Product Code IRP
ProductMorning 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.
Code Information Serial numbers: EMM16100968 and EMM16100967 MFG DATE: 2016.10.10
Recalling Firm/
Manufacturer		 Won Industry Co.
7-12 Bangadari-Gil
Siheung-si Korea (the Republic of)
Manufacturer Reason
for Recall		Distribution of unapproved devices with incorrect air compression level setup
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBeginning 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.
Quantity in Commerce2
DistributionWorldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IRP
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