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510(k) Data Aggregation

    K Number
    K060158
    Device Name
    NET-2000 MICROCURRENT STIMULATOR
    Manufacturer
    Auri-Stem Medical Inc.
    Date Cleared
    2006-10-13

    (266 days)

    Product Code
    QJQ, JXK
    Regulation Number
    882.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Auri-Stem Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Application of electrical current to the head to treat insomnia, depression, or anxiety.
    Device Description
    The NET-2000 Microcurrent Stimulator is a precision electronic instrument used for the treatment of anxiety, depression, or insomnia. The treatment is simple and can easily be selfadministered. The device consists of a microprocessor controller box and skin contact electrodes. The small controller box is a software controlled low-intensity output. Current ranges from 0-600 microamperes typically set at 0.5 Hz. Additional frequencies at 1.5 and 100 Hz are available for the physician's use. The waveform is a bipolar asymmetric rectangular shape. Duty cycle is 50% with a 0 net current. Timed treatment is set at 16.5 minutes.
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