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510(k) Data Aggregation

    K Number
    K980373
    Device Name
    ULTRAMIND BIOFEEDBACK SYSTEM WITH DE-STRESS SOFTWARE
    Manufacturer
    ULTRAMIND INTERNATIONAL LTD.
    Date Cleared
    1998-04-29

    (89 days)

    Product Code
    HCC
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ULTRAMIND INTERNATIONAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultramind Biofeedback System with de-STRESS Software is a biofeedback system designed to be used for relaxation training.
    Device Description
    The Ultramind Biofeedback System comprises a sensor which transmits changes in the stress/relaxation levels to a receiver. In turn, the receiver feeds the information on line to a computer which, by means of the de-STRESS Software, is able to analyze, record, and select data as well as display instructions on how to use the system for the purpose of learning the art of relaxation. The user wears on his/her finger a small plastic mold that contains two electrodes. The electrodes detect minute physiological changes, measured in terms of relative electro-dermal activity (EDA) or galvanic skin response (GSR), that reflect the user's conscious, subconscious or physical state. This information is transmitted by cordless link to a personal computer and is displayed in the form scientific graphs, or used to drive animation. The animation depends on the user's state of mind, i.e., the user is able to change the animation by his/her thoughts or emotions. Through this "play", as the user learns to correlate between thoughts and emotions and the response of the computer game, he/she learns to control physiological responses - even in the realm of the autonomic nervous system. After practice, the user retains the newly-learned capabilities, and can use them at will without the system. The learning process is accelerated through use of advance psychological techniques which enable the user to learn with both hemispheres of the brain, with the intellect and the subconscious.
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