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510(k) Data Aggregation

    K Number
    K062284
    Device Name
    CES ULTRA
    Manufacturer
    NEURO-FITNESS LLC
    Date Cleared
    2007-04-05

    (241 days)

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

    NEURO-FITNESS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CES Ultra™ is indicated for the treatment of insomnia, depression, or anxiety.
    Device Description
    The CES Ultra is a device designed to deliver therapeutic electrical and stimulation for cranial electrotherapy stimulation (CES) applications. The stimulator is powered by a standard 9-volt alkaline battery and delivers a single channel of low-level, constant current electrical stimulation to electrodes connected to the patient's skin via conductive lead wires. Stimulation current is applied to the patient via either standard self-adhering conductive electrodes placed on the head or conductive clip-type electrodes attached to the patient's ear lobes. The stimulator's user controls include: a rotary stimulation amplitude control which allows user adjustment of stimulation current and includes an integral power on/off switch; and a pushbutton timer selector switch which allows user selection of either continuous stimulation or timed stimulation sessions with automatic stimulation shut-off.
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