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510(k) Data Aggregation

    K Number
    K251977
    Date Cleared
    2025-10-22

    (117 days)

    Product Code
    Regulation Number
    884.5160
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is a wearable electric breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

    Device Description

    The electric breast pump (models FZ-P8, YH-P8, YH-P8X) is an electrical wearable breast pump powered by a rechargeable Li-ion battery. It consists of a Pump, Diaphragm, Cup, Valve, Silicone breast shield (flange) and dust cap:

    The pump is the core component of the electric breast pump. It generates a cyclic negative pressure (vacuum) to simulate a baby's sucking motion, drawing milk from the breast into the collection system. The pump is electrically driven and controlled via a motor and control unit, typically offering adjustable suction levels and mode. The diaphragm separates the milk collection system from the pump mechanism, preventing breast milk from entering the pump motor and tubing. The cup is the container that collects and stores the expressed breast milk. The valve controls the one-way flow of breast milk. It opens and closes in sync with the suction cycles to allow milk to flow into the cup while preventing backflow. The silicone breast shield, also known as the flange, is the part that comes into direct contact with the breast. It creates a seal around the nipple and areola to enable effective suction. The dust cap covers the opening of the breast shield or milk collection port when the electric breast pump is not in use. It prevents dust, dirt, and other contaminants from entering the breast pump

    The electric breast pump has 2 (Primary mode and secondary mode) x 3 modes (Massage Mode, Expression Mode, and Mixed Mode), each mode has 10 adjustable levels:

    • Massage Mode provides a vacuum range of 40–190 mmHg and a frequency of 52–110 cycles per minute;
    • Expression Mode provides a vacuum range of 80-280 mmHg and a frequency of 19–75 cycles per minute;
    • Mixed Mode provides a vacuum range of 80-280 mmHg and a frequency of 6–63 cycles per minute.
    AI/ML Overview

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