BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes

    K Number: K231166 · Decision Jan 18, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    3
    Review Days
    268

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
    K Number
    K231166
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zmi Electronics , Ltd.
    Date Received
    April 25, 2023
    Decision Date
    January 18, 2024
    Product Code
    KPI
    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
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

    Similar 510(k) Clearances

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

    Pelvic Muscle Trainer (KM510, KM516B)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Well-Life Incontinence Stimulation System (WL-2405i(P))

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Zmi Electronics , Ltd.

    K Number Device Name
    K241862 Levina Pelvic Floor Muscle Stimulator (RS-48)
    K180865 ZMI Self-Adhesive Electrodes