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510(k) Data Aggregation

    K Number
    K131910
    Device Name
    MPP
    Manufacturer
    Date Cleared
    2014-01-24

    (212 days)

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

    MARC PRO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MPP is 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 and normal household and work activities. The MPP is intended for muscle conditioning by stimulating muscle in order to improve or facilitate muscle performance.
    Device Description
    The MPP consists of a portable battery operated electrical stimulation device with two channels, two sets of lead wires, six packages of self-adhesive electrodes, and a battery charger. Each channel has a pair of buttons to select the desired frequency and a dial to control the intensity of the signal. The stimulator also is supplied with an output jack for each channel, a charging jack, timer buttons, and an LCD display. The device creates stimulation at frequencies of 1-70 Hz depending on the desired effects.
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