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510(k) Data Aggregation

    K Number
    K130676
    Device Name
    AMBIO REMOTE HEALTH MONITORING SYSTEM
    Date Cleared
    2013-07-08

    (118 days)

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

    ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ambio Remote Health Monitoring System ("System") consists of Ambio Wireless Connectors to send readings from off-the-shelf blood pressure and blood glucose meters; the Ambio Scale with built in wireless connectivity to send readings through the Ambio Gateway to the Ambio Care Portal. The Care Portal is used by patients and their caregivers ("Users") to view readings, set reminders to take meter readings and pills, set reading thresholds which will trigger alert messages and set who will get reminder and alert messages. Reading history can be printed or exported. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can set goals and rewards for taking readings and for keeping readings in target ranges. A patient survey tool can be used to gather qualitative health information. The System also has a shared calendar and message board to coordinate among Users. General health information from accredited sources is also available. The Ambio Remote Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The System does not alter the indicated use of the described blood pressure or blood glucose monitors.
    Device Description
    The System consists of: (1) Ambio Wireless Connectors (Wireless Connectors): The Wireless Connector is an electronic device that plugs into the USB port of compatible Blood Pressure Monitors and Blood Glucose Monitors to read the log, encrypt the data, and wirelessly transmit the data to the Ambio Gateway. Readings are sent automatically based on a schedule stored in the Wireless Connector or, the User can push the button on the Wireless Connector to initiate reading the Monitor log and transferring the data. (2) Ambio Scale The Ambio Scale is a stand on digital weight scale with an embedded Ambio Wireless Connector. When the User takes a weight reading, it is then encrypted by the Ambio Wireless Connector and wirelessly transmitted to the Ambio Gateway. (3) Ambio Gateway The Ambio Gateway is an electronic device that connects to the Patient's existing home Internet router using an Ethernet cable. The Ambio Gateway wirelessly receives encrypted data from the Ambio Wireless Connector and transmits it through the user's home broadband internet router to the Ambio Care Portal. (4) Ambio Care Portal The Ambio Care Portal is a secure, web based data base and software application that allows Users to review patient data collected from the described health devices using the Ambio Wireless Connector and Ambio Gateway. The Care Portal is used by patients and their authorized caregivers ("Users") to view readings, set reminders, set personalized thresholds which will trigger alert messages. Reading history can be printed or exported. Users can set goals and rewards for taking readings per their schedule and achieving readings target. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can create patient surveys to gather qualitative information. Users can coordinate using a shared calendar and message board. Health information from accredited sources can also be displayed.
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