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510(k) Data Aggregation

    K Number
    K180298
    Device Name
    welloStationX
    Manufacturer
    Date Cleared
    2018-11-30

    (301 days)

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

    Wello, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The welloStationX is a non-contact infrared forehead thermometer intended for use to measure the body temperature of individuals over 5 years of age and older. The welloStationX can be used by medical professionals or laypersons in any public or private indoor facility with environmental conditions maintained within 15°C to 28°C (59°F to 82.4°F), 20 -70% RH non-condensing.
    Device Description
    The welloStationX uses an infrared sensor to measure human body temperature. It is offered as a desktop or kiosk model. The WSX consists of a display screen with an IR camera mounted to the top of the display screen. The display screen provides instructions to subjects being screened. Both the kiosk and desktop model operate in the same manner. The subject reads and follows the on-screen instructions to position themselves in the correct location approximately 10 inches from the WSX. In 3 seconds, the WSX provides output of the subject's core body temperature. Each temperature reading will be output with either a green background or a red background. Temperature displayed with a red background will also include a prompt to obtain a second temperature evaluation using an alternate method. The facility can select the action threshold or use the default threshold above which the reading will be displayed with a red background. Users can receive email alerts for any subject with a temperature reading displayed with a red background. For some features, an active internet connection is required.
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