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510(k) Data Aggregation

    K Number
    K191571
    Device Name
    UV Radiation Treatment System
    Manufacturer
    Xuzhou Yongkang Electronic Science Technology Co., Ltd
    Date Cleared
    2020-02-06

    (237 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xuzhou Yongkang Electronic Science Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UV Radiation Treatment System models YK-6000A-T, YK-6000B, andYK-6000B-T, are intended for use under the direction of a physician, for the treatment of vitilizo, psoriasis, and eczema. The devices are intended for treatment of these conditions on Fitzpatrick Skin Types (I-VI).
    Device Description
    The proposed device, UV Radiation Treatment System is a portable medical device that consists of tubes, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment. It has four models: YK-6000A,YK-6000A-T,YK-6000B,YK-6000B-T,in which the model YK-6000A and YK-6000A-T emit UVA light and the model YK-6000B and YK-6000B-T emit UVB light. This product has the features are as follows: A. Use Philips special UV lamp as light source, with high stability and long service life: B. Small bulk, lightweight, operation simply, patients can take with themselves; C. There is glisten board inner radiation unit, which can raise radiant efficiency. The UV Radiation Treatment System only can be used in Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of physician.
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    K Number
    K183491
    Device Name
    Arm Blood Pressure Monitor
    Manufacturer
    Xuzhou Yongkang Electronic Science Technology Co., Ltd
    Date Cleared
    2019-03-24

    (97 days)

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

    Xuzhou Yongkang Electronic Science Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Arm blood pressure monitor is used for measuring blood pressure and pulse rate. The monitor can be used in hospitals, families, schools and medical centers. It is suitable for adult, not for neonate or pregnancy.
    Device Description
    The proposed device, Arm Blood Pressure Monitor, is an automatic non-invasive Blood Pressure Monitor which can be driven both battery and AC power supply. It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult, not for neonate or pregnancy. The measuring method for the Arm Blood Pressure Monitor is oscillation mensuration. And all values can be read out in one LCD panel. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data.The blood pressure storing 2x99 set memory value, each measurement it will automatically stored. When it stored 2x99 set memory value, the old value will be covered by the new one. It can show the latest 3 times average value. User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result: User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure, diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power.
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    K Number
    K180314
    Device Name
    Infrared Thermometer
    Manufacturer
    Xuzhou Yongkang Electronic Science Technology Co., Ltd
    Date Cleared
    2018-07-11

    (156 days)

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

    Xuzhou Yongkang Electronic Science Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared 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 Infrared 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. The Infrared thermometer has the following features 1) 1 second measure the temperature. 2) Sensor measurement technology. 3) Automatically power-off, if left idle for 60 seconds. 4) One-key measurement. 5) Prompt for fever. 6) Stores 12 sets recent measurement data for your data contrast. 7) Safety by infrared measuring. YK-IRT1 is divided into System initialization module, Temperature Signal sample module, AD (Analog signal/Digital signal) sample process module, Beyond the threshold process module,Key processing module, Power Manage module,User Interface module.
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    K Number
    K162616
    Device Name
    Wrist Type Blood Pressure Monitor
    Manufacturer
    Xuzhou Yongkang Electronic Science Technology Co., Ltd
    Date Cleared
    2018-03-09

    (535 days)

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

    Xuzhou Yongkang Electronic Science Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wrist Type Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the Wrist. It can be used at medical facilities or at home. The cuff size is 310 mm x 75 mm, and the intended wrist circumference is 13.5 - 19.5 cm.
    Device Description
    The proposed device, Wrist Type Blood Pressure Monitor, is a battery driven automatic non-invasive blood pressure monitor. The Wrist Type Blood Pressure Monitor can automatically complete the inflation, deflation and measurement of systolic and diastolic blood pressure as well as the pulse rate of adult person. User can set different user ID for data storage, which can be set as two independent groups of measured blood pressure data; User can set the time as year, month, day, hour and minute; User can enable or disable the function of voice broadcast about measurement result; User can select the unit of the measurement: mmHg or KPa; The device has the data storage function for data reviewing, including the data of systolic pressure. diastolic pressure, pulse rate and measurement time. The device has low power indicator to indicate the states of low batteries power.
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    K Number
    K161938
    Device Name
    Fingertip Pulse Oximeter
    Manufacturer
    XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD
    Date Cleared
    2017-05-08

    (298 days)

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

    XUZHOU YONGKANG ELECTRONIC SCIENCE TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,
    Device Description
    The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude; The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring. The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.
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