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510(k) Data Aggregation

    K Number
    K203148
    Device Name
    Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
    Date Cleared
    2021-07-08

    (259 days)

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

    Ningbo Youhe Electrical Appliance Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The electric breast pumps are intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user. The electric breast pumps are intended for at home use.
    Device Description
    The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YY-8011 and YH-8019 have a single pumping configuration only. A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel keypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing. The device has three modes of operation: Massage mode: Suction patterns with fast cycles and low vacuum to start milk flowing; Low expression mode: Suction patterns with slow cycles and high vacuum to express more milk gently and efficiently; High expression mode: Suction patterns with slower cycles and higher vacuum to express more milk efficiently. THE ONE, YH-8012 and BB-5020 have 3 modes including massage mode, low expression mode and high expression mode. YY-5030, YH-8011, and YH-8019 have 2 modes including massage mode and high expression mode. The device is electrically powered from either an internal lithium ion rechargeable battery or an external AC power adapter. The external adapter also charges the battery.
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