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510(k) Data Aggregation

    K Number
    K131675
    Device Name
    BODIHEALTH SYSTEM
    Date Cleared
    2014-03-12

    (278 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    EPRT TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EPRT Bodihealth TENS System (Transcutaneous Electrical Nerve Stimulator for Pain Relief) with Silver Wrap is intended for temporary symptomatic relief and management of chronic intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic pain.
    Device Description
    The Bodihealth TENS system was previously described in K052836. The Silver Wrap is the component of the Bodihealth System that is used to transfer the energy from the Bodihealth device to the patient. It consists of a MediSponge foam 100 to which silver fabric is laminated, and then covered by urethane. The silver wrap is one-piece and consists of (a) a Urethane outer layer, (b) an adhesive layer, (c) a silver plated nylon conductive layer and (d) a foam layer that acts as the material that contacts the patient. The silver wrap functions as the means to conduct a maximum current of 3 milliamperes at 0.000732 Hz for 23 minutes. The electric currents produced are compatible with the natural electric currents of the human body.
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