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510(k) Data Aggregation

    K Number
    K230214
    Device Name
    Huma RPM (RPM)
    Manufacturer
    Date Cleared
    2023-06-02

    (127 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medopad Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Huma platform is a modular software as a medical device (SaMD) which may utilize compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient's home setting. It is intended for the monitoring of patients by trained healthcare professionals.
    Device Description
    The Huma RPM is a digital remote patient monitoring platform that empowers patients to better manage their own health. The modular solution tracks symptoms and vital signs, flags deterioration, incorporates telemedicine functionality and can be connected to other medical devices. Data from the App is surfaced and analyzed in the Portal which has flagging for easy triage and decision making. The Portal enables clinicians to safely monitor patients, spot deterioration and intervene early to improve outcomes and avoid unnecessary clinic, outpatient and hospital attendance. The portal can display information about individual patients and visualize data trends. Clinicians can add notes and collaborate with colleagues to ensure the patient receives the optimal care they need. The platform also has messaging capability and telemedicine for patient video consultations. The platform can be integrated with EHR systems and existing patient portals. The clinician portal also allows for Role-Based-Access-control (RBAC) based on a person's role within the healthcare facility according to data view rights for different healthcare system personnel.
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