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510(k) Data Aggregation

    K Number
    K223622
    Device Name
    FaceHeart Vitals Software Development Kit (FH vitals SDK)
    Manufacturer
    FaceHeart Corp.
    Date Cleared
    2023-09-01

    (270 days)

    Product Code
    QME
    Regulation Number
    870.2785
    Why did this record match?
    Applicant Name (Manufacturer) :

    FaceHeart Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias. While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not replace, the user's usual professional medical care and/or medication. If abnormalities are detected during the measurement with the FH Vitals SDK, users are advised to consult a medical professional. The FH Vitals SDK is indicated for use in humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. This software should not be the primary or sole method for assessing an individual's health.
    Device Description
    FH vitals SDK is a video-based, non-contact pulse rate measurement software with a face recognition function designed to measure and real-time display the pulse rate of adults. This system uses cameras to detect the user's face and obtains the continuous face image data, with signal processing and algorithm to compute the pulse rate. The software is intended to be installed on commercial mobile devices/laptops/computers equipped with cameras. It can be deployed on Android, iOS platform and Windows platforms.
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