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

    Viberect Penile Vibratory Stimulation Device

    K Number: K142304 · Decision Oct 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    46

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    Basic Information

    Device Name
    Viberect Penile Vibratory Stimulation Device
    K Number
    K142304
    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
    August 18, 2014
    Decision Date
    October 3, 2014
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KXQ), ordered by most recent decision date.

    VIBERECT PENILE VIBRATORY STIMULATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MULTI CARE THERAPEUTIC VIBRATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    FERTICARE PERSONAL THERAPEUTIC VIBRATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Reflexonic, LLC

    K Number Device Name
    K110566 VIBERECT PENILE VIBRATORY STIMULATION DEVICE