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

    Pelvic Floor Exerciser (PF01)

    K Number: K252748 · Decision Apr 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    6
    Review Days
    241

    Basic Information

    Device Name
    Pelvic Floor Exerciser (PF01)
    K Number
    K252748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1425
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hunan Accurate Bio-Medical Technology Co., Ltd.
    Date Received
    August 29, 2025
    Decision Date
    April 27, 2026
    Product Code
    HIR
    Advisory Committee
    Obstetrics/Gynecology
    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
    HIR Perineometer

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    Other Clearances by Hunan Accurate Bio-Medical Technology Co., Ltd.

    K Number Device Name
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    K240808 Pulse Oximeter (WS20A)
    K171241 Pulse Oximeter
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