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510(k) Data Aggregation

    K Number
    K221708
    Device Name
    CIMILRE Free-T2 Plus
    Manufacturer
    Cimilre Co., Ltd.
    Date Cleared
    2022-12-23

    (193 days)

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

    Cimilre Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CIMILRE Free-T2 Plus / CIMILRE Free-T2 is an electrically powered breast pump intended to express and collect breastmilk from lactating women. The device is intended to be used by a single user.
    Device Description
    The Cimilre Free-T2 Plus and Cimilre Free-T2 are electrically powered wearable single breast pumps consisting of the following key components: a breast shield, valve, milk bottle cap, silicone backflow protector, nipple, locking ring, and C-type USB cable. The main body is powered by a rechargeable internal battery facilitating a motor and solenoid valve to generate suction pressure for breast pumping. The device is electronically operated with a microprocessor controlled by integrated software to provide a range of adjustable vacuum pressure and cycle rates. Pumping can be performed on one breast (single pumping) in wearable mode. The user interface allows the user to switch from massage to expression mode and control the vacuum levels within those modes. Both massage and expression mode consist of 12 total vacuum levels (5 massage, 7 expression). Both models are capable of providing vacuum levels from 50-130 mmHg with cycling rates from 55-70 cycles per minute in massage mode and vacuum levels from 150-280 mmHz with cycling rates from 27-51 cycles per minute in expression mode. The subject devices are powered by a 3.7 V 1200 mA internal rechargeable lithium-ion polymer battery. The motor unit operates on embedded software. The Free-T2 Plus model can communicate wirelessly via Bluetooth with smartphone devices. Software updates by endusers are not supported. The subject devices are for repeated use by a single user in a home environment. The devices are provided not sterile. The breast pump expresses by creating a seal around the nipple using the breast shield and applying and releasing suction to the milk is collected in a milk collection container, which can be used for storage. To prevent milk from flowing into the vacuum system, a backflow protection membrane physically separates the milk-contacting pathway from the vacuum system. All other components (i.e., motor unit) of the subject device are not in contact with the breast. The motor unit operates on a rechargeable battery and does not function when charging. The rechargeable battery can be charged from the external USB adapter if the motor unit is not in operation.
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    K Number
    K162870
    Device Name
    CIMLRE F1 and CIMILRE S3
    Manufacturer
    CIMILRE CO., LTD.
    Date Cleared
    2017-03-07

    (145 days)

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

    CIMILRE CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CIMILRE F1 and CIMILRE S3 are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
    Device Description
    This device is designed to express and collect milk from the breast of a lactating woman. When operated in mode, the device generates the pressure through the interaction of the diaphragm pump and the solenoid electric mechanism. The device adopts the microprocessor that can control the procedure to set and adjust the vacuum levels and cycles of Massage Mode and Express Mode. Two Modes are pre-programmed with variable vacuum levels and cycle rates (pump speed). The device is capable of providing vacuum levels from 40 to 280 mmHg with cycle rates up to 60 cycles per minute. The CIMLIRE F1 and S3 are intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. The CIMILRE F1 is powered by a 12 VDC adaptor or rechargeable lithium battery. The CIMILRE S3 is powered only by a 12VDC adaptor.
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