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    K Number
    K232466
    Device Name
    Electric Breast Pump, model: YM-8166
    Manufacturer
    Guangdong Youmeng Electrical Technology Co., Ltd.
    Date Cleared
    2024-01-19

    (157 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangdong Youmeng Electrical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electric Breast Pump Model: YM-8166 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
    Device Description
    The Electric Breast Pump Model: YM-8166 is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
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