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510(k) Data Aggregation

    K Number
    K201977
    Device Name
    TempTraq
    Manufacturer
    Blue Spark Technologies Inc.
    Date Cleared
    2020-12-03

    (140 days)

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

    Blue Spark Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wireless thermometers are battery-operated electronic devices with intended use of measuring human body temperature precisely. The devices are single-use and intended for armpit temperature measurement for persons of all ages.
    Device Description
    TempTraq is a single-use device used to monitor temperature. The type of temperature that can be taken by the TempTraq patch is axillary only. The TempTraq temperature patches consist of a flexible circuit board that is positioned between two pieces of foam. The TempTraq temperature sensor patch is applied to the patient via foam that is backed with a biocompatible adhesive and transmits body temperature data via low energy Bluetooth transmission to a smart device running a TempTraq application. The patch is worn on the underarm and senses, processes, stores, and transmits temperature data to a smart device running a compatible TempTrag application using Bluetooth LE.
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    K Number
    K143267
    Device Name
    TempTraq TT-100
    Manufacturer
    Blue Spark Technologies Inc.
    Date Cleared
    2015-09-02

    (293 days)

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

    Blue Spark Technologies Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Wireless thermometer, model TT-100, is a battery-operated electronic device with intended use of measuring human body temperature precisely. This device is single-use and intended for armpit temperature measurement for persons of all age.
    Device Description
    The TempTraq™, Model TT-100 patch consists of a temperature sensor integrated circuit mounted to a flexible electronic printed circuit board that also contains a microprocessor and a Bluetooth Low Energy (BLE) radio transmitter. Two 1.5V flexible batteries are attached to the circuit board to supply 3.0V DC internal power. The temperature sensor integrated circuit utilizes diode technology where voltage varies with temperature. The sensor circuit is factory calibrated and converts the voltage to an output temperature. The algorithm for conversion is a proprietary algorithm which compensates for the nearly linear behavior of the diode voltage, providing an extremely accurate temperature measurement.
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