BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Pelvic Muscle Trainer (KM510, KM516B)

    K Number: K260178 · Decision Jun 18, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    7
    Review Days
    148

    Basic Information

    Device Name
    Pelvic Muscle Trainer (KM510, KM516B)
    K Number
    K260178
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Konmed Technology Co., Ltd.
    Date Received
    January 21, 2026
    Decision Date
    June 18, 2026
    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 (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

    Regenesis EMS Chair

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

    Other Clearances by Shenzhen Konmed Technology Co., Ltd.

    K Number Device Name
    K233576 Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
    K220161 Biofeedback Nerve and Muscle Stimulator
    K202648 Biofeedback Nerve and Muscle Stimulator
    K163288 Pelvifine Pelvic Muscle Trainer
    K171722 Electrodes with snap / Electrodes with pigtail
    K171721 Electrodes with silver conductive