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    K Number
    K013094
    Device Name
    ORTHOSONIX ENERGEX
    Manufacturer
    ORTHOSONIX, INC.
    Date Cleared
    2001-12-14

    (88 days)

    Product Code
    NHH
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHOSONIX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Energex is indicated for use for the temporary relief of chronic temporomandibular joint (TMJ) pain.
    Device Description
    The Energex is a therapeutic medical device that delivers pulsed radio-frequency energy to tissue as indicated for the relief of chronic TMJ pain.
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