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510(k) Data Aggregation

    K Number
    K170769
    Device Name
    wireless thermometer
    Date Cleared
    2017-07-26

    (134 days)

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

    ECH (Changzhou) Medical Instrument Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. The system is intended for armpit temperature monitoring for persons with all ages. The products can be used in hospital and at home.
    Device Description
    The MCU chip in the wireless electronic thermometer collects the voltage value of the NTC thermal resistor, a thermo-sensitivity resistance, whose resistance will change according to temperature. After collecting and filtering algorithm, a resistance value data is obtained. After that, the Bluetooth chip performs a table lookup operation to find the Celsius temperature value corresponding to the resistance value. The temperature data is transmitted through the Bluetooth transmission to the compatible smart phone, in order to achieve the function of temperature measurement. The wireless thermometer is composed of a Patch and a Mobile App. Patch: One side of Patch is medical adhesive which is used to fix the patch on the armpit of patients. The other side is foam. There is a circuit board inside the patch. The patch is used for detecting of human body temperature and then transferred to Mobile App for display and further management. There is no display function on the patch, except for a indicator to indicating power on/off status. Patches are single use only, and available in different configuration. The models ECH-b1-S, ECH-b1-M and ECH-b1-L all share the same design principles, materials, mechanism of actions. However they are different in size and intended patient. Mobile APP: The APP is intended for display and management of obtained human body temperature data.
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