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510(k) Data Aggregation

    K Number
    K131933
    Device Name
    ELECTRONIC PULSE MASSAGER
    Date Cleared
    2013-12-20

    (176 days)

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

    GURIN PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    The Santamedical Pulse Stimulator, a Transcutaneous Electrical Nerve Stimulator (TENS), is for overthe-counter use and for home use, which is intended to relieve pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities. The portable and microprocessor-controlled Santamedical Pulse Stimulator delivers a gentle electrical pulse through two channels with four attachment pads and shows graphic information about mode style, intensity and time remaining on a LCD based display which is incorporated within the device body.
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