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510(k) Data Aggregation

    K Number
    K242725
    Device Name
    Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)
    Manufacturer
    Ningbo Youhe Electrical Appliance Technology Co.,Ltd.
    Date Cleared
    2025-05-30

    (262 days)

    Product Code
    HGX
    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 Authorized
    Intended Use
    The Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) are powered breast pumps intended to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.
    Device Description
    The subject devices are wearable-style breast pumps designed for lactating women to express and collect milk from the breast. They are electrically powered, software controlled, digital pumps for a single user. The subject devices include The INs, The INs Gen 2, The INs NEXT, P1s, and P3 models, which are capable of expression, massage, and mixed modes with ten associated suction levels for each. All five models have a single pumping configuration and can be operated in 'normal' or 'quiet' modes. Massage, expression, and mixed pumping modes consist of 10 vacuum levels. Each Youha and BEBEBAO electric breast pump model is capable of providing vacuum levels from 40-190 mmHg with cycling rates from 90-110 cycles per minute in massage mode, vacuum levels from 80-280 mmHg with cycling rates from 40-75 cycles per minute in expression mode, and vacuum levels from 80-280 mmHg with cycling rates from 6-46 cycles per minute in mixed mode. The Youha electric breast pump is charged with a 5 V DC adaptor and powered by an internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. Software updates by end-users are not supported. The subject devices do not have wireless capability or other external functionality (i.e., no Bluetooth or mobile application). The subject device is for repeated use by a single user in a home environment. The device is provided not sterile. The motor unit operates on a rechargeable battery and can function when charging. The breast pump expresses milk by creating a seal around the nipple using the breast shield and applying and releasing suction to the nipple. The milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit/housing) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
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    K Number
    K163136
    Device Name
    Youha electric breast pump
    Manufacturer
    NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD.
    Date Cleared
    2017-07-31

    (265 days)

    Product Code
    HGX
    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 Authorized
    Intended Use
    The Youha electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
    Device Description
    The Youha electric breast pump is a single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. YH-8004 and YH-8016 have both single (pumping from one breast) and double pumping (pumping from both breasts) configurations. YH-8006IV and YH-8015 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 280mmHg. The user interface consists of a front panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure. 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. YH-8004, YH-8015 and YH-8016 have 3 modes including massage mode, low expression mode and high expression mode. YH-8006IV has 2 modes including massage mode and high expression mode. The device is electrically powered from either an internal rechargeable battery or an external AC power adapter. The external adapter also charges the battery.
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