BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VIBERECT PENILE VIBRATORY STIMULATION DEVICE

    K Number: K110566 · Decision Jun 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    116

    Basic Information

    Device Name
    VIBERECT PENILE VIBRATORY STIMULATION DEVICE
    K Number
    K110566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    REFLEXONIC, LLC
    Date Received
    February 28, 2011
    Decision Date
    June 24, 2011
    Product Code
    KXQ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KXQ Vibrator For Therapeutic Use, Genital

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    Other Clearances by REFLEXONIC, LLC

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    K142304 Viberect Penile Vibratory Stimulation Device