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510(k) Data Aggregation

    K Number
    K200545
    Device Name
    Legend Pro DMA
    Manufacturer
    Pollogen, Ltd
    Date Cleared
    2021-10-21

    (597 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pollogen, Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles. Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment.
    Device Description
    The Legend Pro DMA generates a sequence of electrical pulses which are delivered to the skin overlaying the muscles intended to be stimulated. The Legend Pro DMA consists of a floormounted, rolling System Console that generates voltage output delivered though metal electrodes in the three different DMA Applicators. The System Console generates electrical pulses, and delivers modulated low frequency rectangular biphasic waveforms via electrodes incorporated in different Applicators connected to the System Console: - . LP DMA Applicator No. 1 for large Areas (includes 6 stainless-steel equidistant electrodes) - . LP DMA Applicator No. 2 for Medium areas (includes 3 stainless-steel equidistant electrodes) - LP DMA Applicator No. 3 for Small Areas (includes 3 stainless-steel equidistant ● electrodes) The Legend Pro DMA is controlled by a proprietary embedded SW. The system SW provides the treatment parameters. The hardware (HW) then implements the actual pulse generation according to the parameters provided by the software. Via the GUI in the System Console, the physician selects the Applicator according to the size of the area being treated and the treatment parameters (Frequency, % Height/Amplitude, pulse width and Treatment Duration). During the treatment session, the operator moves the Applicator across the skin that is lubricated with glycerine.
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