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

    Wearable breast pump (model W8)

    K Number: K242850 · Decision Feb 21, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    243
    Applicant Total
    21
    Review Days
    154

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    Basic Information

    Device Name
    Wearable breast pump (model W8)
    K Number
    K242850
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen TPH Technology Co., Ltd.
    Date Received
    September 20, 2024
    Decision Date
    February 21, 2025
    Product Code
    HGX
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGX Pump, Breast, Powered

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    Other Clearances by Shenzhen TPH Technology Co., Ltd.

    K Number Device Name
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    K252420 Wearable Breast Pump (Model W12)
    K252422 Wearable Breast Pump (Model W2)
    K251754 Wearable Breast Pump (Model S33)
    K250383 Wearable Breast Pump (Model W6)
    K250843 Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)
    K250350 Thrive 2-in-1 Breast Pump (Model P3)
    K250368 Wearable Breast Pump (Model S21)
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