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510(k) Data Aggregation

    K Number
    K020211
    Device Name
    BODY FORCE, MODEL BT 6000
    Date Cleared
    2002-06-28

    (157 days)

    Product Code
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    COMPOSITES SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BODY FORCE is a medical device used on patients who have experienced an abdominal/ pelvic crush injury. The purpose is to prevent a decrease in the central blood volume during transportation to a trauma center. Indications for use are: (Tourniquet) 1) Uncontrollable hemorrhaging in the leg(s)
    Device Description
    The BODY FORCE is a composite board, measuring eighteen inches (18") long and eight inches (8") wide and seven-eighths inches (7/8") thick with a loose strap on one side that is two inches (2") wide and seventy inches (70") long. On the other side is a strap that is also two inches (2") wide but only six inches (6") long with a metal ratchet sewn into it. The straps are sewn into a three sixteenth inch (3/16") X fourinch (4") wide stainless steel hinges, with a non-removable pin. The hinges will be held down to the plate by a cam-lock that passes through the board in slots that enable it to be adjusted to several different sizes. There is also a long gated eyebolt that locks into the center of the board that is designed to be used as a bilateral tourniquet for the lower extremities.
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