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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.

FDA Recall Z-0204-2018 · Posted None

Recalling FirmWon Industry Co.
Recall StatusTerminated
Product CodeIRP
Date Initiated2017-01-13
Date Terminated2023-05-24
Product Quantity2

Reason for Recall

Distribution of unapproved devices with incorrect air compression level setup

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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