Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K202802
    Device Name
    TT Electric Breast Pump, TT Double Electric Breast Pump
    Manufacturer
    Wuxi Xinzhongrui Baby Supplies Co., Ltd.
    Date Cleared
    2021-08-26

    (337 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Xinzhongrui Baby Supplies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. This powered breast pump is intended for a single user and is intended to be used in a home environment.
    Device Description
    The TT Electric Breast Pump and TT Double Electric Breast Pump are intended to express and collect milk from the breast of a lactating woman. The devices are intended for a single user. The subject devices are for repeated use by a single user and are for use in home and professional healthcare environments. The devices are not sterile. The subject devices are electrically powered double (TT Double Electric Breast Pump) and single (TT Electric Breast Pump) breast pumps consisting of the following key components: a motor unit with a press-button user interface, pump body, LCD display, air tube connectors, and breast milk collection bottles. The motor unit operates on embedded software. Software updates by end-users are not supported. The breast pump extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the nipple. The milk is collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a protection membrane physically separates the milkcontacting pathway from the vacuum system. The motor unit operates on a rechargeable battery or on an external mains adapter that is provided with the system via a micro-USB type connection. The rechargeable battery can be charged from the external mains adapter if the motor unit is not in operation. All other components of the subject devices are not in contact with the breast.
    Ask a Question
    K Number
    K142479
    Device Name
    MEGNA BREAST PUMPS
    Manufacturer
    WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.
    Date Cleared
    2015-02-24

    (173 days)

    Product Code
    HGX
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    WUXI XINZHONGRUI BABY SUPPLIES CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The powered Megna Breast Pumps are intended to express and collect milk from the breast of a lactating woman. The M5 model is a single pump. The M7, M10, and M12 models are double pumps with a single pumping option. All models are intended for single users.
    Device Description
    The Megna breast pumps are electrically powered breast pumps for over-the-counter use, intended to be used at home to express a nursing mother's breast milk. The Megna breast pumps are provided in 4 models: Model M5 - Megna Digital Single Breast Pump, Model M7 Megna Digital Double Breast Pump, Model M10 - Megna Digital Double Breast Pump, Model M12 - Megna Digital Double Breast Pump.
    Ask a Question

    Page 1 of 1