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510(k) Data Aggregation

    K Number
    K240218
    Device Name
    Electric Breast Pump (F5055)
    Date Cleared
    2024-10-17

    (265 days)

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

    **Fimilla (Shanghai) maternity **& baby Articles Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric Breast Pump (F5055) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.
    Device Description
    The Electric Breast Pump (F5055) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Electric Breast Pump (F5055) is intended for a single user. The proposed device is electrically powered and software-controlled. The device operates via a microprocessor-driven air pump, which generates suction on the breast to extract milk. The proposed device is available in one model, F5055. The provided non-sterile and is not to be sterilized by the user prior to use. The device includes a breast shield assembly, bottles, pump unit, tubing, an adapter, and pump unit. The breast shield assembly includes a silicone breast shield and polypropylene breast shield body that contacts the user's breast.
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