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510(k) Data Aggregation

    K Number
    K252754

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (112 days)

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

    The Wearable electric breast pump (Model: YM-8803) is a powered 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 Wearable electric breast pump (Model YM-8803) is a powered 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. The device is provided not sterile and should be cleaned and disinfected according to the instructions for use.

    The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk container.

    The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed.

    To prevent milk from flowing into the vacuum system, the milk collection set includes a diaphragm that physically separates the milk-contacting pathway from the vacuum system. The motor unit operates on a rechargeable battery. The rechargeable battery can be charged from the external power adaptor specified in IFU (not included) through the provided USB charging cable. The user interface features four buttons and an LED display, allowing the user to navigate between modes and adjust the vacuum pressure.

    The subject device has two modes: Stimulation and Expression.

    AI/ML Overview

    N/A

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