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510(k) Data Aggregation

    K Number
    K243146
    Device Name
    iCare APP
    Manufacturer
    iHealth Labs, Inc.
    Date Cleared
    2025-02-03

    (126 days)

    Product Code
    MWI, DXN, OCH, OUG, PUH
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    iHealth Labs, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCare App is intended for use in the home and clinical settings as and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team. The iCare App can also connect to medical devices and or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.
    Device Description
    The iCare APP is a mobile application on both Android and iOS platforms.iCare allows users to better manage their own health by enabling them to measure their vital signs, access their results and relevant health information with just their smart device and internet connection, and receive feedback from their professional care team. iCare includes a patient darshboard featuring the Home, Health, Plus, Education, and Profile tabs. Accessory devices can be connected to the system to allow for collection of blood sugar, blood pressure, blood oxygen, and/or weight measurements. The patient darshboard functionality includes the ability to start measuring, allows users to view and track measurements, and export testing schedules for blood sugar, blood pressure, blood oxygen, and weight measurements; send messages to their professional care team; view previous appointment history information; view medication instructions; add entries to the food diary and review feedback from their registered dietician; set timers; and access articles and videos about health knowledge.
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