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510(k) Data Aggregation

    K Number
    K150923
    Device Name
    Breast Pump
    Date Cleared
    2015-11-06

    (214 days)

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

    Guangzhou Jinxinbao Electronic Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BR128 Breast Pump is an electrically powered suction device intended to express and collect milk from a lactating woman's breasts. This is for a single user.
    Device Description
    The BR128 is an electrically powered breast pump that uses negative pressure to express milk from the breasts of lactating women. It adopts a Single-Chip Microcomputer to imitate a baby's suckling action and a reciprocating vacuum pump to generate the suction to extract the milk at vacuum levels between 0 and 170mmHg. It is intended for single pumping. It is designed to mechanically interface with a mother's breast via a massage cushion and withdraw then collect the breast milk. The motor unit of the device is connected to the bottle via a silicone tube. Its suction strength is adjustable via the suction adjustment button on the device, but its cycles per minute are controlled by software and cannot be adjusted. The device can be powered by batteries or the provided mains adapter.
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    K Number
    K130231
    Device Name
    NON-CONTACT INFRARED THERMOMETER
    Date Cleared
    2013-10-15

    (259 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    JINXINBAO ELECTRONIC CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    JXB182 Non-contact Infrared Thermometer is an infrared thermometer intended to measure forehead temperature of infants and adults without contacting human body. It can be used by consumers in household environment and doctor in clinic as reference.
    Device Description
    All objects, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The JXB-182 infrared thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken thanks to an external temperature probe on the device which permanently analyses and registers the ambient temperature. Therefore, as soon as the operator holds the thermometer near the forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment. The JXB-182 thermometer without contact has been developed using latest infrared technology . This technology allows temporal artery (TA) temperature to be taken at a distance of about 5cm away from the forehead. Then the result will be displayed on LCD. Besides, it owns Led backlight which can show three different colors in different temperature ranges and three-language prompt function.
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    K Number
    K130232
    Device Name
    ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM
    Date Cleared
    2013-09-17

    (231 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    JINXINBAO ELECTRONIC CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BPA-002 Electronic Blood Pressure Monitor for Upper Arm is intended to measure systolic and diastolic blood pressures as well as the determination of heart rate by using the oscillometric method. All values can be read out in one LCD panel. It is suitable for adult arm circumference and can be used by medical departments or for home use. However, it shouldn't be used by people who have severe arrhythmia.
    Device Description
    BPA-002 Electronic Blood Pressure Monitor for Upper Arm uses an inflatable cuff which is wrapped around the patient's upper arm. The cuff is inflated automatically by an internal pump in the device. The systolic and diastolic blood pressures are determined by oscillometric method and silicon integrate pressure sensor technology. The deflation rate is controlled by a preset mechanical valve at a constant rate. The pressure of the cuff is completely released automatically at the end of measurement. At the same time, the measurements are displayed on the LCD display for 60 seconds. There is a maximum pressure safety setting at 280mmHg. The device will not inflate the cuff higher than 280mmHg. It will display an irregular heartbeat symbol if an irregular heartbeat was detected during the measurement process. In addition, it has LCD backlight. After 60 seconds without operation, the blood pressure monitors turn off automatically
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