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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 Life see related information
Date Initiated by Firm January 13, 2017
Create Date December 06, 2017
Recall Status1 Open3, Classified
Recall Number Z-0205-2018
Recall Event ID 78182
510(K)Number K120166  
Product Classification Massager, powered inflatable tube - Product Code IRP
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.
Code Information none
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
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.
Quantity in Commerce 3
Distribution Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IRP and Original Applicant = WON INDUSTRIAL CO.
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