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

    Wearable Breast Pump (Model S21)

    K Number: K250368 · Decision May 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    202
    Applicant Total
    11
    Review Days
    109

    Basic Information

    Device Name
    Wearable Breast Pump (Model S21)
    K Number
    K250368
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen TPH Technology Co., Ltd.
    Date Received
    February 10, 2025
    Decision Date
    May 30, 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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    K242850 Wearable breast pump (model W8)
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    K223886 Wearable Breast Pump (Model S18)
    K220596 Wearable Breast Pump (Model S9)
    K212180 Wearable Breast Pump (Model S12)
    Search all 11 clearances from Shenzhen TPH Technology Co., Ltd. →