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510(k) Data Aggregation

    K Number
    K181013
    Device Name
    Fever Scout
    Manufacturer
    VivaLnk Inc.
    Date Cleared
    2018-08-21

    (126 days)

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

    VivaLnk Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use and a non-invasive and single patient use in the hospital. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
    Device Description
    The VivaLnk Fever Scout VV-200 is an ambulatory continuous body temperature monitor designed for armpit location, and uses Bluetooth Low Energy (BLE) for wireless communication with the Smartphone app for temperature display, trending and alert. The product is composed of The Fever Scout VV-200 patch, The Smartphone app (supporting Apple iOS and Android devices), AAA charging system with BLE relay function, Eight disposable adhesives.
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    K Number
    K162137
    Device Name
    Fever Scout™ Continuous Monitoring thermometer
    Manufacturer
    VivaLnk Inc.
    Date Cleared
    2017-01-19

    (171 days)

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

    VivaLnk Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
    Device Description
    Fever Scout Continuous Monitoring thermometer is an ambulatory continuous body temperature monitor designed for armpit location, and uses Bluetooth Low Energy (BLE) for wireless communication with the Smartphone app for temperature display, trending and alert. This product is composed of The Fever Scout VV-200 patch, The Smartphone app (supporting iOS), AAA charging system with BLE relay function, and Eight adhesives. The patch hardware primarily includes the following function modules: 1) temperature sensor, 2) control module, 3) Bluetooth Low Energy (BLE) communication module and 4) battery. All are integrated onto a flexible electronic printed circuit board. A MS Lithium rechargeable battery is attached to the board to supply 3.0V DC internal power. The app includes 1) User account, profile and alert temperature setup and 2) GUI for temperature display, trending and alerts. The charging system provides a cordless charging method to the patch, a storage to the replaceable double-sided adhesives, as well as an alternative BLE communication channel from the patch to the charger and then to the iPhone, in order to extend communication range. This product contains Type B applied part (per IEC 60601-1: 2012). All components, the patch, charger and adhesives are all user accessible parts. However, the user is only expected to change the charger AAA batteries, but not to open or modify any other parts of the product.
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