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510(k) Data Aggregation

    K Number
    K150923
    Device Name
    Breast Pump
    Date Cleared
    2015-11-06

    (214 days)

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

    Guangzhou Jinxinbao Electronic Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BR128 Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.
    Device Description
    The BR128 is an electrically powered breast pump that uses negative pressure to express milk from the breasts of lactating women. It adopts a Single-Chip Microcomputer to imitate a baby's suckling action and a reciprocating vacuum pump to generate the suction to extract the milk at vacuum levels between 0 and 170mmHg. It is intended for single pumping. It is designed to mechanically interface with a mother's breast via a massage cushion and withdraw then collect the breast milk. The motor unit of the device is connected to the bottle via a silicone tube. Its suction strength is adjustable via the suction adjustment button on the device, but its cycles per minute are controlled by software and cannot be adjusted. The device can be powered by batteries or the provided mains adapter.
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