Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K173730
    Device Name
    Kinsa QuickCare Thermometer
    Manufacturer
    KINSA, Inc.
    Date Cleared
    2018-01-17

    (42 days)

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

    KINSA, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kinsa QuickCare Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.
    Device Description
    The Kinsa QuickCare Thermometer is a battery powered, thermistor based predictive Bluetooth low energy (BLE) enabled thermometer used for the measurement and monitoring of human body temperature. Body temperature can be measured with the Kinsa QuickCare Thermometer orally, axillary (under the arm), and rectally. The thermometer is reusable for clinical and/or home use on people of all ages with adult supervision. The device can be used with as a standalone device or in conjunction with the Kinsa App on a compatible BLE enabled smartphone.
    Ask a Question
    K Number
    K132514
    Device Name
    KINSA SMART THERMOMETER
    Manufacturer
    KINSA, INC.
    Date Cleared
    2013-12-02

    (112 days)

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

    KINSA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Kinsa Smart Thermometer is intended to measure the human body temperature orally, rectally, or under the arm, and the devices are reusable for clinical or home use on people of all ages.
    Device Description
    The Kinsa Smart Thermometer product is a thermometer that connects to a Smartphone or another mobile device (e.g. an iPod Touch). The product will read body temperature the same way a clinical digital thermometer does by being placed under the tongue in the mouth, rectum or alternatively, or under the arm. Like other clinical digital thermometers, the Kinsa Smart Thermometer is a thermistor-based product; however, it has the advantage of being read on a mobile device display. Unlike other clinical digital thermometers, the Kinsa Smart Thermometer product requires no batteries or LCD displays. The Kinsa Smart Thermometer is reusable for clinical or home use on people of all ages. The Kinsa Smart Thermometer will connect to Smartphones or other mobile devices via a headphone jack that accepts a microphone input. In this document the terms Smartphone, smartohone and mobile device are used interchangeably and are defined to include the following products: Apple iPhones 5, 4S and the Apple iPod Touch 5. The Kinsa Smart Thermometer consists of four components: - A. Thermometer (probe). - B. An adapter to setup each Smartphone for temperature reading (only needed once per Smartphone). - C. An optional, flexible extension cord that can be used to lengthen the distance between the thermometer and Smartphone so users can see the Smartphone screen while taking a temperature. - D. Software.
    Ask a Question

    Page 1 of 1