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    K Number
    K052357
    Device Name
    PATHWAY - ATS/CHEPS
    Manufacturer
    MEDOC LTD. ADVANCED MEDICAL SYSTEMS
    Date Cleared
    2006-01-19

    (143 days)

    Product Code
    NTU
    Regulation Number
    882.1870
    Why did this record match?
    Product Code :

    NTU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PATHWAY- ATS/CHEPS is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.
    Device Description
    The PATHWAY- ATS/CHEPS is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as a stimulator for creating sensation and pain stimuli, in the sensory nerves fibers.
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    K Number
    K051448
    Device Name
    MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS)
    Manufacturer
    MEDOC LTD. ADVANCED MEDICAL SYSTEMS
    Date Cleared
    2005-06-29

    (27 days)

    Product Code
    NTU
    Regulation Number
    882.1870
    Why did this record match?
    Product Code :

    NTU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified Contact Heat-Evoked Potential (CHEPS) is indicated finaloations in evaluating the functionality of human pain reception and transmission of sensory pathways.
    Device Description
    The Modified Contact Heat-Evoked Potential Stimulator (CHEPS) is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as a stimulator for creating sensation and pain stimuli, in the sensory nerves fibers.
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    K Number
    K041908
    Device Name
    CONTACT HEAT-EVOKED POTENTIAL STIMULATOR (CHEPS)
    Manufacturer
    MEDOC LTD. ADVANCED MEDICAL SYSTEMS
    Date Cleared
    2005-02-25

    (225 days)

    Product Code
    NTU
    Regulation Number
    882.1870
    Why did this record match?
    Product Code :

    NTU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Contact Heat-Evoked Potential Stimulator (CHEPS) is indicated for the use in evaluating the functionality of human pain reception and transmission of sensory pathways.
    Device Description
    The Contact Heat-Evoked Potential Stimulator (CHEPS) is a computerized thermal stimulator that produces a heating stimulation in rate of 70°C/sec, enabling delivery of painful stimuli from a baseline to 55℃ in 250 milliseconds. The system consists of the CHEPS control unit, external cooling unit, 27mm diameter thermode probe, thermode cables, and software. The software program requires the use of an IBM compatible notebook or desktop computer, which is not supplied. Also, the following are optional components: MRI-safe thermode and cables and cart.
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