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510(k) Data Aggregation

    K Number
    K134004
    Device Name
    VERIZON WIRELESS CONVERGED HEALTH MANAGEMENT DEVICE
    Date Cleared
    2014-02-14

    (49 days)

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

    CELLCO PARTNERSHIP D/B/A VERIZON WIRELESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CHM Device is a remote monitoring software solution intended to collect and store biometric data from physiological measurement devices intended for use in the home. The CHM Device also allows for the automated transmission of the biometric data to a remote secure server via an existing mobile telecommunications and/or internet infrastructure. The stored biometric data is accessible by clinicians for analysis and intervention. Patients can also review the stored biometric data and receive educational and motivational content from clinicians. The CHM Device can be used as a standalone device or in conjunction with supported patient monitoring devices, such as a glucometer, weight scale, pulse oximeter, and blood pressure monitor. The CHM Device is not intended for use in surgical rooms, intensive care units, intermediate or step-down units or emergency vehicles. It is not interpretive, nor is it intended for diagnosis or as a replacement for the oversight of healthcare professionals. It does not provide real-time or emergency monitoring.
    Device Description
    The CHM is a software platform for the collection and display of biometric data, primarily from externally supported patient monitoring devices, both to the patient and to the clinician. The CHM Device may also be used as a standalone device. The CHM Device uses existing Internet and telecommunications architecture (cell phones and computers) for the automated transmission of medical data to a remote secure server from where it can be viewed remotely by clinicians and patients for the purposes of storage and basic analysis. The CHM Device also provides educational and motivationalities allowing the clinician to send tasks, recommendations, surveys, and educational and motivational messages to patients.
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