Intel-Ge Care Innovations, LLC
Intel-Ge Care Innovations, LLC holds FDA 510(k) medical device clearances, cleared in 2013, with 4 FDA device recalls on record.
Top product codes for Intel-Ge Care Innovations, LLC
FDA recalls by Intel-Ge Care Innovations, LLC
- Z-2442-2018 — 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.
- Z-1374-2013 — QuietCare-Networked. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
- Z-1375-2013 — QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community.
- Z-0877-2013 — QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Intel-Ge Care Innovations, LLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.