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510(k) Data Aggregation

    K Number
    K974626
    Device Name
    P.T. MACHINE
    Date Cleared
    1998-02-06

    (57 days)

    Product Code
    Regulation Number
    890.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    **GOODMAN, GOODMAN **& GOODMAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To provide paraspinal treatment in the form of articulation pressure, beat, and vibration.
    Device Description
    The P.T. Machine and the predicate devices are AC-powered physical therapy tables that consist of rollers-to-provide articulation pressure, a heat source to provide heat therapy, and a vibrational source to provide massage therapy. Moreover, all three devices are programmable devices that may be programmed either by the Chiropractor or the patient.
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