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510(k) Data Aggregation

    K Number
    K251377
    Device Name
    Magic InBra
    Manufacturer
    Medela AG
    Date Cleared
    2025-09-18

    (139 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K200508
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Magic InBra™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts.

    The Magic InBra™ powered breast pump is intended for a single user.

    This breast pump is intended to be used in a home environment.

    Device Description

    The Magic InBra wearable breast pump is a single user pump to be used by lactating women to express and collect milk from their breasts in the home environment. Magic InBra is designed to fit most breast shapes and nursing bras allowing hands-free pumping. The pump is intended to be used by a single user for pumping on one breast with one Magic InBra breast pump or on both breasts at the same time with two Magic InBra breast pumps.

    An optional smartphone application (app) for iPhone and Android, called "Medela Family Pump Control", connects to the breast pump via Bluetooth and, once connected, allows the user to control the breast pump remotely.

    AI/ML Overview

    N/A

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