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510(k) Data Aggregation

    K Number
    K112312
    Device Name
    THERATRODE
    Manufacturer
    PHOENIX MEDICAL DEVICES, LLP
    Date Cleared
    2012-01-25

    (167 days)

    Product Code
    GXY, 882, NEU
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOENIX MEDICAL DEVICES, LLP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin. Single patient use - re-usable. Self adhering and re-positionable. Over the counter use.
    Device Description
    Theratrode electrodes are constructed as a layered assembly comprised of four components: - A patient contacting layer of hydrogel material which has been tested and . found to be bio-compatible with humans and provides both the electrically conductive medium necessary to aid in the transmission of electrical current to the patient plus the adhesive properties necessary to maintain sufficient contact with the patient's skin. - A carbon dispersion pad middle layer that evenly distributes the electrical . current across the surface of the electrode, - A non-conductive top layer of various materials such as spun lace (fabric), . polyethylene or polypropylene foam or other similar materials that form a protective and flexible top layer to the electrode. - A wire or conductive carbon fiber lead wire which is glued to the assembly . of the middle and top layer and terminates in a .080" (2mm) female connector common to the electrotherapy industry and which mates with the plurality of commercially available nerve stimulation devices on the market today. The female connector complies with IEC60601-1 Sub clause 56 3(c). Theratrode electrodes are non-sterile and are intended for multiple use by a single patient to apply electrical stimulation. Theratrode's construction is equivalent to the predicate device's construction.
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