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    K Number
    K061676
    Device Name
    RIGIDOMETER, MODEL DIR-4U
    Manufacturer
    UROAN 21
    Date Cleared
    2006-12-27

    (196 days)

    Product Code
    LIL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    UROAN 21

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uroan DIR-4U Rigidometer measures penile axial rigidity.
    Device Description
    The DIR-4U Rigidometer consists of an instrument and attached sensor that measures penile axial rigidity. It has been designed, so that men can use this instrument in the privacy of their homes to measure their penile axial rigidity.
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