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510(k) Data Aggregation

    K Number
    K223329
    Device Name
    Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201)
    Manufacturer
    Guangzhou Yongyi Industrial Co., Ltd.
    Date Cleared
    2023-05-26

    (207 days)

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

    Guangzhou Yongyi Industrial Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electric Breast Pumps are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
    Device Description
    The subject devices are intended to be used by lactating women to express and collect milk from their breasts. The devices are intended for a single user in the home environment or hospital setting. When properly connected, the pumping kit transfers the vacuum generated by the powered pump to the breast, enabling expression and collection of milk. A diaphragm in the backflow protection assembly physically isolates pump and tubing from the space where milk is expressed and collected, protecting the breast milk from contamination. The Electric Breast Pumps contain 4 models, YY-A203, YY-A204 and YY-TC201. The YY-A46 model operates in single pumping mode only; models YY-A203, YY-A204 and YY-TC201 can be operated in single or double pumping modes. Models YY-A203 and YY-A204 have an LED panel and model YY-TC201 has an LCD panel to display working mode, cycle, timer, battery level, and Bluetooth symbol to user. While YY-A46 has an LED indicator to indicate the working status of the device, models YY-A46, YY-A203, and YY-A204 can be wirelessly operated via Bluetooth connection to a smart device. Users can select the working mode, adjust the suction level and cycle speed, and start or pause the device from a smart device. Model YY-TC201 can only be operated on the pump unit itself. All models have massage and expression mode and have a maximum working time of 30 minutes.
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    K Number
    K192640
    Device Name
    Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
    Manufacturer
    Guangzhou Yongyi Industrial Co., Ltd.
    Date Cleared
    2020-03-30

    (188 days)

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

    Guangzhou Yongyi Industrial Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.
    Device Description
    The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are single-user powered breast pumps capable of single pumping. The subject devices are powered by a rechargeable lithium ion battery or AC adapter. They are non-sterile. The powered breast pumps' drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over vacuum pressure and cycle speed. Models YY-A11, YY-A21 and YY-A41 are capable of single pumping and have two modes: - Massage mode: Helps to relax the muscle around the breast and prepare for suction. - Normal mode: Suction patterns are characterized by low vacuum to start milk flow. In addition to the two modes described above, Models YY-A31, YY-A103, YY-A103, YY-A104, and BF103 are capable of single pumping and have an additional mode: - Rapid mode: Suction patterns are characterized by high vacuum to express more milk. Model BF100 is capable of single and double pumping and has two modes only: - Letdown mode: Helps to relax the muscle around the breast and prepare for suction. - Expression mode: Suction patterns are characterized by high vacuum to express more milk.
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