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510(k) Data Aggregation

    K Number
    K110334
    Device Name
    WALDO PATIENT MONITOR
    Manufacturer
    Date Cleared
    2011-04-12

    (67 days)

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

    WALDO HEALTH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Waldo Patient Monitor is a remote patient monitor device available by prescription. The Waldo Patient Monitor is designed to be used in the home of a patient undergoing remote monitoring for maintenance of chronic disease. The Waldo Patient Monitor provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and real-time video conferencing technology. The Waldo Patient Monitor connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. The Waldo Patient Monitor stores and displays the information on the LCD screen and transmits the information to the Waldo Health secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless Internet or Ethernet. Healthcare professionals can review the transmitted information utilizing the Waldo Health Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded. The Waldo Health 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 is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered. A list of devices that are compatible with the Waldo Patient Monitor will be available in the user's manual and the Waldo Health website.
    Device Description
    The Waldo Patient Monitor is a remote patient monitoring device available via prescription. The Waldo Patient Monitor connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the Waldo Health secure server. Healthcare professionals can review the transmitted information utilizing the Waldo Health Clinician Access System. The Waldo Health System consists of: 1. Waldo Health System Hardware: The physical component of Waldo Health System is the Waldo Patient Monitor. which is an electronic device contained in an acrylonitrile butadiene styrene (ABS) thermoplastic enclosure with a touch screen, built-in video camera. microphone, speaker, and a reminder light ("light bar") mounted on top of the case. The Waldo Patient Monitor contains front and back panels that provide standard USB 2.0 connectors, Ethernet connector, power connector and power button, as well as volume controls. 2. Waldo Patient Monitor Software Application: The Waldo Patient Monitor executes the Waldo Patient Monitor Software Application, which connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. stores and displays the information on the LCD screen and transmits the information to the Waldo Health secure server. 3. Waldo Health Clinician Access System (CAS) Software Application: The Waldo Health Clinician Access System (CAS), which is associated with and manages multiple Waldo Patient Monitor devices, is designed to allow doctors and nurses to create and access electronic health records as well as provide a user-friendly interface into a patient's health condition. The Waldo Health System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. The system is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
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