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510(k) Data Aggregation

    K Number
    K024377
    Device Name
    TRANSCRANIAL ELECTROTHERAPY STIMULATOR-A, MODEL TESA-1
    Manufacturer
    KALACO SCIENTIFIC, INC.
    Date Cleared
    2003-07-21

    (202 days)

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

    KALACO SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment with the TESA device is intended to reduce the symptoms of depression, anxiety and insomnia.
    Device Description
    The TESA is a transcranial electrotherapy stimulation device. Three electrodes are applied, one to the forehead and one behind each ear. TESA delivers low amplitude AC current for a desired time of 0 to 99:59 minutes. Treatment can be stopped by pressing the "current off" button. Either the operator or patient may press this button at any time. During treatment, peak current amplitude can be adjusted over the available range of 0 - 4 mA. Treatment parameters are monitored and controlled by a built in microprocessor. The display on the front of TESA indicates remaining treatment time and shows the current setting. During treatment, a modulated high frequency square wave is delivered to the patient electrodes. The amplitude and duration of the positive and negative going portions of this waveform have been carefully designed to deliver no DC component. Moreover, the electrodes are AC coupled to the patient to insure no DC component in the event of device failure. Additional safety features of the TESA device include rapid measurement of electrode impedance to insure good electrode contact and to maintain controlled current output over changing load conditions (e.g. when electrode contact changes). Detection of poor electrode contact causes the device to stop treatment and illuminate an electrode fault LED. Further treatment is blocked until electrode/skin impedance is restored to nominal range.
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