BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇱 Israel

    vPatch

    K Number: DEN210012 · Decision Nov 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    238

    Basic Information

    Device Name
    vPatch
    K Number
    DEN210012
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.5026
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Virility Medical
    Date Received
    March 30, 2021
    Decision Date
    November 23, 2021
    Product Code
    QRC
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QRC Non-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation

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