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510(k) Data Aggregation

    K Number
    K243629
    Device Name
    Momcozy Wearable Breast Pump (BP311); Momcozy Wearable Breast Pump (BP223); Momcozy Wearable Breast Pump (BP324); Momcozy Wearable Breast Pump (BP334); Momcozy Wearable Breast Pump (BP430)
    Manufacturer
    Shenzhen Root Innovation Technology Co., Ltd.
    Date Cleared
    2024-12-20

    (25 days)

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

    The Momcozy Wearable Breast Pump (Model: BP311, BP223, BP334, BP334, BP430) is 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

    Not Found

    AI/ML Overview

    This document pertains to the FDA clearance of a medical device, specifically a breast pump. It does not contain information about the acceptance criteria or study details for an AI/ML-enabled medical device.

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-enabled device based on the provided text. The document is a standard FDA 510(k) clearance letter for a non-AI medical device.

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