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    K Number
    K050123
    Device Name
    P-STIM SYSTEM
    Manufacturer
    NEUROSCIENCE THERAPY CORP.
    Date Cleared
    2006-03-30

    (435 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEUROSCIENCE THERAPY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The P-Stim is a miniaturized, battery-powered, transcutaneous electrical nerve stimulator that has a pre-programmed frequency, pulse, and duration for the stimulation of auricular acupuncture points. The device connects via three stainless steel wires to acupuncture needles that have been applied to the appropriate auricular acupuncture points. The device is powered by three zinc air batteries, each with a voltage of 1.4 V. The device is on for 180 minutes, then off for 180 minutes, for a maximum period of up to 96 hours.
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