Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K153026
    Device Name
    Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement
    Manufacturer
    MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS
    Date Cleared
    2016-05-25

    (222 days)

    Product Code
    IYE, LNH
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated to assist in the proper positioning of patients for radiation therapy including electron, photon and proton treatments, and simulation including CT and MR image acquisition.
    Device Description
    The Respiratory Plate with Cushion and Respiratory Belt are components of a modularbased patient positioning system that indexes directly to a treatment or simulation couch. The Respiratory Plate is comprised of a compression plate, mount, index screw, and screw wheel. Rotation of the screw wheel lowers and raises the compression plate. The mount is attached to the positioning system bridge using pins, and the bridge is indexed to the system platform using a clamping mechanism. A Cushion is mounted on the compression plate via pocket features on the Cushion. The Cushion is comprised of three compartments of beads plus an air chamber. The Cushion is inflated with air to the desired pressure using a hand-held pump accessory with reference pressure qauge. The Respiratory Belt is comprised of a central air chamber with indexing scale. Velcro straps, hand pump, pressure gauge, and clamps. The Velcro straps allow the Belt to be tightened or loosened around the patient. The Belt is inflated using a hand pump and the pressure is monitored with a reference pressure gauge. Clamps are used to attach the Velcro straps to the positioning system platform. The Respiratory Plate with Cushion and Respiratory Belt are reusable devices that are provided non-sterile and are manufactured of non-magnetic materials with the exception of the pressure gauge. The devices are used in a healthcare facility/hospital.
    Ask a Question

    Page 1 of 1