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510(k) Data Aggregation

    K Number
    K210435
    Device Name
    Automatic Arm Electronic Blood Pressure Monitor
    Date Cleared
    2021-05-12

    (89 days)

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

    Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is a digital monitor intended to measure the diastolic, systolic blood pressures and pulse rate in adult patient population by using a non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm of which the circumference includes 22 cm to 32 cm (8.7 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches). It can be used in hospital environment or at home.
    Device Description
    The Automatic Arm Electronic Blood Pressure Monitor, including LBP70C and LBP70D, can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult patient with arm circumference ranging from 22 cm to 32 cm (8.7 inches to 12.6 inches) or 22 cm to 42 cm (8.7 inches to 16.5 inches) by the oscillometric technique. User can select the blood pressure unit mmHg or KPa. The device has irregular heat beat (IHB) indicator which can indicate a rhythm 25% less or 25% more than the average rhythm detected while measuring the systolic and diastolic blood pressure. The subject device consists of the PCBA, pressure sensor, operation keys, pump, control valve, LCD screen, cuff, batteries and optional accessory AC adapter. The two models have same intended use, working principle, measuring range, accuracy, cuff, component and appearance. They are only different in power supply. Model LBP70C is powered by 4 AA alkaline batteries or AC adapter, while model LBP70D is powered by rechargeable lithium-polymer battery or AC adapter. The device has a memory function that can automatically store up to 90 sets of data for each user. It can also display the latest measurement result.
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    K Number
    K202776
    Device Name
    Fingertip pulse oximeter
    Date Cleared
    2021-03-01

    (161 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fingertip pulse oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospital-type facilities, and homecare.
    Device Description
    Fingertip pulse oximeter, LOX100A, LOX100B, LOX100C, LOX100D, mainly include of signal acquisition module, signal processing module, prompt module, detector, and emitter LED, display and user interface module, power supply module, the device is used to measure the patient's blood oxygen saturation (SpO2) and pulse rate (PR). The device is mainly composed of main board PCB, lamp panel PCB, sensor, OLED screen, button, silicone gel pad and enclosure.
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    K Number
    K202687
    Device Name
    Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
    Date Cleared
    2021-02-18

    (156 days)

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

    Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Infrared Forehead Thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
    Device Description
    The subject device Infrared Forehead Thermometer has three models: LFR30B, LFR50 and LFR60. The three modes have same operation principle. A thermopile sensor is employed to detect the infrared energy emitted from the surface of the skin of the forehead which is converted into temperature measurement with the unit of degree C or degree F. The results can be displayed on LCD. The measurement is non-contact with the patient. The measuring distance is 0~5 cm to the forehead and the measuring time is 1s. The Infrared Forehead Thermometer is battery powered.
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