Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K252629
    Date Cleared
    2025-10-27

    (68 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 HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

    Device Description

    The Electric Breast Pump (Models HL-3058, F5112) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
    Electric Breast Pump (Models HL-3058, F5112) also has a hot function which provides hear to the users neck for warmth. It does not affect the intended use of the product.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1