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510(k) Data Aggregation

    K Number
    K042686
    Device Name
    ENERGEX
    Manufacturer
    ENERGEX SYSTEMS, INC.
    Date Cleared
    2005-06-16

    (260 days)

    Product Code
    NHH
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    NHH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Energex® system is intended to be used as an adjunct to medical therapy for the temporary symptomatic relief of mild to moderate chronic anterior knee pain which is not caused by meniscal, ligament, or cartilage injury.
    Device Description
    Not Found
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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?
    Product Code :

    NHH

    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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