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510(k) Data Aggregation

    K Number
    K130360
    Device Name
    CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM - MULTI-USER VERSION
    Manufacturer
    Date Cleared
    2013-07-15

    (152 days)

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

    CONSTANT CARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAH Home Health Monitoring System is designed to be used in the home of a patient or healthcare setting to provide remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System provides guidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and realtime video conferencing technology. The Constant Care LILAH Home Health Monitoring System connects to commercially available wireless and wired medical devices such as glucose meters, weight scales, blood pressure monitors, electronic thermometers, peak-flow meters and pulse oximeters. The Constant Care LILAH Home Health Monitoring System stores and displays the information on a computer screen and transmits the information to the Caretaker Portal secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless, Internet, or Ethernet. Healthcare professionals and remote caregivers can review the transmitted information unilizing the Caretaker Portal and set thresholds to trigger non-emergency alerts based on specific thresholds being exceeded. The Constant Care LILAH Home 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 timecritical 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.
    Device Description
    The Constant Care LILAH Home Health Monitoring System - Multi-User Version is a software device consisting of two components: patient-side software to be installed on hardware compatible with an Asus EeeTop PC ET1611PUT 15.6 inch TouchScreen Atom D425 All-in-One PC, or an Acer ICONIA Tab W500-C52G03iss 10.1' LED Tablet PC for use in performing patient monitoring, and sending data to the Caretaker Portal secure host server; and caregiver-side software for receiving patient-side data and transmitting that data to healthcare professionals and remote caregivers through the Caretaker Portal secure host server. The patient-side software component is offered in two different versions. The single-user version, designated as "LILAH Version 1.1," is designed to be used by one individual, and is streamlined for simplicity of use. The multi-user version, designated as "LILAH Multi-User," allows for multiple individuals to be monitored through a single application. Changes covered by this clearance are applicable to both the LILAH Multi-User and LILAH Version 1.1 versions of the patient-side software component. The Constant Care LILAH Home Health Monitoring System - Multi-User Version is a remote patient monitoring device available with or without prescription designed to be used in the home or healthcare setting of patients undergoing remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System - Multi-User Version can be used to monitor and track a single patient or multiple patients. The Constant Care LILAH Home Health Monitoring System - Multi-User Version 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.
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    K Number
    K120941
    Device Name
    CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM
    Manufacturer
    Date Cleared
    2012-07-03

    (96 days)

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

    CONSTANT CARE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Constant Care LILAH Home Health Monitoring System is a non-emergency, delayed, remote patient monitoring device available by prescription. The Constant Care LILAH Home Health Monitoring System is designed to be used in the home of a patient or healthcare setting to provide remote monitoring for maintenance of chronic disease. The Constant Care LILAH Home Health Monitoring System provides guidance in operating medical sensor devices: reminders for medication compliance and connectivity to healthcare professionals through text messaging and realtime video conferencing technology. The Constant Care LILAH Home Health Monitoring System connectally available wireless and wired glucose meters, weight scales, blood pressure monitors, medication reminders, and pulse oximeters. The Constant Care LILAH Home Health Monitoring System stores and displays the information on a computer screen and transmits the information to the Caretaker Portal secure host server using connectivity including, but not limited to, FCC approved Wi-Fi, Cellular Wireless, Internet, or Ethernet. Healthcare professionals and remote caregivers can review the transmitted information utilizing the Caretaker Portal and set thresholds to trigger non-emergency alerts based on specific thresholds being exceeded. The Constant Care LILAH Home 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 timecritical care is not required. The device is contraindicated for patients requiring direct medical 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 Constant Care LILAH Home Health Monitoring System will be available in the user's manual and the Constant Care website.
    Device Description
    The Constant Care LILAH Home Health Monitoring System consists of two components: patient-side software to be installed on either an Asus EeeTop PC ET1611PUT 15.6 inch TouchScreen Atom D425 All-in-One PC, or an Acer ICONIA Tab W500-C52G03iss 10.1' LED Tablet PC for use in performing remote patient monitoring, and sending data to the Caretaker Portal secure host server; and caregiver-side software for receiving patient-side data and transmitting that data to healthcare professionals and remote caregivers through the Caretaker Portal secure host server.
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