11 results
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75ms
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Sources: EU EUDAMED, US FDA
QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04; QC200405 (USA) and QCE200403, v.02; QCE200403, v.03 (UK). Manufacturer Living Independently Group, Inc., New York, NY. QuietCare is intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code IQA·July 30, 2011
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code IQA·April 4, 2013
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code KMI·December 16, 2012
QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code IQA·April 4, 2013
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code OUG·December 6, 2017
Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on label: Manufacturer Living Independently Group, Inc., A wholly owned subsidiary of General Electric Company, PO Box 1466, New York, NY 10116 USA, 1-866-772-8243 --- The system is a passive behavior-monitoring device. QuietCare uses strategically placed, unobtrusive, passive wireless infrared pyroelectric sensors in the senior's residence to detect their movement. Data from these sensors are sent to a base station that periodically transmits the information to a centralized secure file server through standard phone lines over a toll-free number. Sophisticated algorithms analyze the data, learning each individual's normal patterns of behavior. When the system detects significant deviations from these baselines it automatically alerts designated caregivers. QuietCare also generates alerts of late wake-ups, potential bathroom falls and if household temperatures become dangerously low or high. The behavioral changes that the system tracks can often serve as subtle indicators of the potential emerging health problems. These changes include: nighttime bathroom usage, entering or exiting the bedroom at a different time than usual, change in the number of times the refrigerator door is opened/closed change in the number of times the medicine cabinet door is opened/closed. The intended users of the QuietCare device are the caregivers at the Assisted Living Facilities and Independent Living Facilities. The monitored individuals (seniors) do not actively operate the device and the device function is not dependent upon the senior resident's ability to use the device. --- Class 2 device, 510(k) exempt, Device Listing Number D117156.
FDA Recall
Terminated
·Intel-GE Care Innovations LLC·Product code IQA·August 1, 2011
Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.
FDA Enforcement
Class II
·Terminated·Intel-GE Care Innovations LLC·July 25, 2018
QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
FDA Enforcement
Class II
·Terminated·Intel-GE Care Innovations LLC·March 6, 2013
QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
FDA Enforcement
Class II
·Terminated·Intel-GE Care Innovations LLC·June 5, 2013
QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
FDA Enforcement
Class II
·Terminated·Intel-GE Care Innovations LLC·June 5, 2013
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