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510(k) Data Aggregation

    K Number
    K171406
    Device Name
    Optum TeleHealth Application
    Date Cleared
    2017-08-18

    (98 days)

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

    United Health Group Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application. The Optum TeleHealth Application is not intended for emergency use or real-time monitoring. The client application is available in three configurations: - stand-alone application for both Android and iOS operating systems - pre-loaded on an Android tablet
    Device Description
    The Optum TeleHealth Application is client/server software application which collects and transmits patient vital signs, and physiological data for review, and analysis by clinicians. The software consists of a web based application for clinician use, the client application for member use, and web services. Standard data communication protocols are used. The server hosts the web based application for user management, and patient information and care management. The client application is designed to work with Android devices (OS 4.0 and higher) and Apple devices (iOS 9 and higher), and allows for data input from external biometric measuring devices, review of clinician advice, response to clinician questions, and viewing of graphed data. The client application is available in two configurations: - stand-alone application for both Android and iOS operating systems . - . pre-loaded on an Android tablet The device is used in combination with various Class I 510(k) exempt devices and FDA cleared biometric measuring devices, including, but not limited to: - A&D Medical, UA-767PBT Digital Blood Pressure Monitor (K043217) . - . A&D Engineering Inc., UC-321PBT Weight Scale (510(k) exempt) - TaiDoc Technology Corporation, Fora W310 Weight Scale (510(k) exempt) . - . TaiDoc Technology Corporation, Fora IR20b Ear Thermometer (K090395) - TaiDoc Technology Corporation, Fora P20 Blood Pressure Monitor (K092106) ● - Nonin Medical Inc Onyx II Model 9560 Finger Pulse Oximeter (K081285) ●
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