Pro Trainers' Choice Company

  • Dirección del fabricante
    Pro Trainers' Choice Company, PO BOX 27, 26129 Calvary Lane NE, Suite 200, Kingston WA 98346
  • Source
    USFDA
  • 1 Event

Un dispositivo en la base de datos

  • Modelo / Serial
    The affected serial numbers range from 100116 to 100452.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution including CA, CO, FL, IN, KS, NY, OR, TX, and WI.
  • Descripción del producto
    Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). || The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. || The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***info@precisionice.com***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". || The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". || The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". || The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".