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510(k) Data Aggregation

    K Number
    K972000
    Device Name
    X-RAY ASSIST BAR
    Manufacturer
    Date Cleared
    1997-07-08

    (39 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    RALPH LINDEL, D.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended to accurately position the patient's body in a steady, precise position during X-Ray procedures (erect lateral thoracic, lateral lumbar, lateral chest and lateral abdomen plain film X-Rays).
    Device Description
    Lower bar adjusts and locks to the horizontal position for the patient to hold onto and adjusts down to the vertical position so it can be moved close to the wall and out of the way when not in use. Once the lower bar is in the horizontal position, the handle can be loosened and the height adjustment bar can be raised or lowered as well as be moved left or right along the tracks to adjust for differing patient heights and arm lengths. The device can have two sets of tracks; one on either side of the X-Ray bucky. The height adjustment bar/lower bar/front block/rear block assembly can be removed by removing the set screw in the stop block between the end of the tracks, sliding the height adjustment bar/lower bar/front block/rear block assembly off the tracks and then sliding it onto the second set of tracks and putting the set screw in the stop block at the end of the second set of tracks.
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