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

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

    K Number: K252552 · Decision May 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    6
    Review Days
    266

    Basic Information

    Device Name
    Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
    K Number
    K252552
    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 Changkun Technology Co., Ltd.
    Date Received
    August 13, 2025
    Decision Date
    May 6, 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

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