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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
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To provide paraspinal treatment in the form of articulation pressure, heat, 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.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on Goodman's P.T. Machine. The document is a 510(k) summary for a physical therapy table, focusing on its substantial equivalence to predicate devices. It discusses similarities in intended use, principles of operation, and technological characteristics, and explicitly states that "The minor differences among the devices do not raise any new questions of safety or effectiveness."

    Therefore, I cannot provide the requested information regarding acceptance criteria and studies.

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