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510(k) Data Aggregation

    K Number
    K020211
    Device Name
    BODY FORCE, MODEL BT 6000
    Manufacturer
    COMPOSITES SOLUTIONS, INC.
    Date Cleared
    2002-06-28

    (157 days)

    Product Code
    JOW
    Regulation Number
    870.5800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called "BODY FORCE," a compressible limb sleeve intended for abdominal/pelvic crush injuries and as a tourniquet.

    However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a submission to the FDA for substantial equivalence to a predicate device, not a report of performance testing against specific criteria.

    Therefore, I cannot provide the requested information from the given text.

    To address your request, the document would need to include:

    • A section detailing specific performance metrics (e.g., pressure exerted, effectiveness in reducing blood flow, durability, ease of use).
    • Quantitative measurements for these metrics.
    • A description of a study (e.g., clinical trial, bench testing, animal study) conducted to evaluate these metrics.
    • Details about sample size, ground truth, expert involvement, etc., for any such study.
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