4 results
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75ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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