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510(k) Data Aggregation

    K Number
    K230102
    Device Name
    Smart double sides wearable breast pump, Electric bilateral breast pump
    Date Cleared
    2023-09-21

    (251 days)

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

    Huizhou LVB Maternal And Infant Supplies Co,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.
    Device Description
    The Wearable Breast Pump is an electrically powered, software controlled, digital, single user, wearable breast pump for lactating women to express and collect milk from the breast. The subject device is capable of expression and stimulation modes, with nine associated suction levels for each. The vacuum pressure ranges from 80-200 mmHg for stimulation mode and 90-240 mmHg for expression mode. The device is powered by a rechargeable battery or a power adapter. The device has an LED display, which shows the power button, pumping mode, suction level, timer, and battery charge level. Surrounding the front panel display are soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression modes, and control the vacuum strength. The breast pump expresses by creating a seal around the nipple using the flange and applying and releasing suction to the breast. The milk is collected in a milk collection container. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system.
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