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510(k) Data Aggregation

    K Number
    K140681
    Device Name
    BELTER INFRA-RED EAR THERMOMETER
    Manufacturer
    SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
    Date Cleared
    2014-08-21

    (156 days)

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

    SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Belter Infra-red Ear thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages for home and professional use.
    Device Description
    The Belter Infra-red Ear Thermometer is characterized by measuring human body temperature from the ear canal. It utilizes infrared technology to measure infrared energy emitted from eardrum tissue when making a temperature measurement.
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    K Number
    K134029
    Device Name
    BELTER BLOOD PRESSURE METER
    Manufacturer
    SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
    Date Cleared
    2014-07-25

    (206 days)

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

    SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Belter Blood pressure meter is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person. It can be used at medical facilities or at home. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
    Device Description
    The Belter Blood pressure meter can automatically complete the inflation,deflation and measurement .which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person with arm circumference ranging from 22 cm to 36cm by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The device consists of the microprocessor, pressure sensor, operation keys, pump, deflation control valve and LCD. The subject device is powered by four AA alkaline batteries. The device has a memory function that automatically stores up to 60 sets of the latest measurements. It can also display the latest measurement result. The subject device embeds a Bluetooth that allows it to transport the measurement data to nearby receiving end. The device also detects the appearance of irregular heartbeats during measurement. and gives a warning signal with readings.
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    K Number
    K122976
    Device Name
    BODY FAT SCALE MODEL SF-371
    Manufacturer
    SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
    Date Cleared
    2013-01-04

    (100 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale SF-371 measures body weight, and estimates body fat, body water, body muscle mass and body bone mass using BIA (bioelectrical impedance analysis). The device is intended to be used by generally healthy people (from age 16 to age 80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
    Device Description
    The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd. Body Fat Scale calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
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