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510(k) Data Aggregation

    K Number
    K222398
    Device Name
    Care Team Portal
    Manufacturer
    Vivify Health, Inc.
    Date Cleared
    2023-02-06

    (182 days)

    Product Code
    DRG
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vivify Health, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Care Team Portal is intended to support management of health conditions. It allows a clinical user to configure the collection of patient data. The Care Team Portal includes the ability to notify the patient and the clinical user when the parameters fall outside set limits and customize patient specific recommendations.
    Device Description
    Vivify Remote Patient Monitoring consists of the Care Team Portal, patient portals, and accessory devices. The Care Team Portal allows the clinical user to view and manage patient information. The functionality includes the ability to add new users and patients, ability to schedule video visits, secure in-app messaging, configure the collection of patient data leveraging care pathways survey questions, educational content and videos with customized notifications, and prioritize patients. It provides a dashboard view of the patients being monitored. The patient portals enable the patient to provide subjective symptom or health status information that assists the care team in supporting the management of health conditions: +Home is an option that provides the patient with software pre-loaded on a tablet that allows them to navigate through care pathways for the collection of patient data and view educational content related to their health condition. +Go is designed for patients to download the software to their own mobile device to navigate through care pathways for the collection of patient data and delivery of educational content related to their health condition. +Voice allows patients to answer their pathways questions and enter data using their phone. Accessory devices can be connected to the system to allow for collection of vital signs or used independently to allow for manual input.
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