FDAFDA · Alimentos y medicamentos·N.º oficial Z-0205-2018
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.
Publicado el 13 de diciembre de 2017 · Inicio del retiro: 13 de enero de 2017
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Distribution of unapproved devices with incorrect air compression level setup
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Won Industry Co.
- Distribuidor
- Worldwide distribution - US Nationwide - Domestic: MD & TX; Internationally: Mexico
- Lote
- none
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Korea (the Republic of)
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