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510(k) Data Aggregation

    K Number
    K231625
    Device Name
    VitalDetect
    Manufacturer
    Date Cleared
    2024-02-02

    (245 days)

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

    Wellvii Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP). This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology. The VitalDetectTM is applicable for prescription home use by individuals 18 years of age or older for monitoring. The device is not intended for continuous monitoring.
    Device Description
    VitalDetect is a Bluetooth® connected, hand-held, portable vital sign monitor for prescription home use. The monitoring device can read physiological parameters, including: Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP), and Body Temperature (TEMP). The device uses a lithium-polymer battery which is rechargeable by the User. The battery is replaceable only by service personnel. The VitalDetect monitoring system consists of a measurement device with inflatable finger-cuff, 5 finger shims, USB charging cord, and a downloadable application (APP) for use on a mobile device.
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