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510(k) Data Aggregation

    K Number
    K060125
    Device Name
    SONIC PALPOMETER
    Manufacturer
    PALPOMETER SYSTEMS, INC.
    Date Cleared
    2006-03-16

    (57 days)

    Product Code
    IKE
    Regulation Number
    890.1615
    Why did this record match?
    Product Code :

    IKE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Sonic Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and freatments that use digital palpation.
    Device Description
    The Palpometer is a simple device that combines the fine motor and sensory attributes of manual examination with the precision measurements made with pressure gauges. By measuring the amount of pressure between the device and a soft tissue, the Palpometer standardizes pain response by controlling the pressure of the examiner's palpating finger. The Palpometer consists of a thin sensor, positioned on the palpating portion of the examiner's finger. The sensor changes its electrical resistance caused by varying the pressure exercised by the examining finger. The Palpometer beeps in a different tone as you pass through each programmable pressure threshold (of which there are five).
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