FDA Medical Device Recalls (openFDA)
Won Industry Co.: 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.
- Recall number
- Z-0205-2018
- Recalling firm
- Won Industry Co.
- 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.
- Status
- Terminated
- Initiated
- 2017-01-13
- Posted
- not on file
- Terminated
- 2023-05-24
- Reason
- Distribution of unapproved devices with incorrect air compression level setup
- Root cause
- 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
- 3
- Distribution
- Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
- Lot, serial or model codes
- none
- 510(k) numbers
- ["K120166"]
- PMA numbers
- not on file
- Product code
- IRP
- Firm FEI
- 3005515255
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28