Intel-Ge Care Innovations, LLC
Roseville, CA, US
Intel-Ge Care Innovations, LLC appears in FDA device records in Roseville, CA. FDA records list 3 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Intel-Ge Care Innovations, LLC in 2013.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K131585 | INTEL-GE CARE INNOVATIONS QUIETCARE | KMI | Substantially Equivalent | |
| K130821 | INTEL-GE CARE INNOVATIONS CONNECT RCM | DRG | Substantially Equivalent | |
| K130290 | MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE | DRG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | It was discovered that in certain situations, including partial sessions and when taking adhoc measurements, the patient data was not synchronizing in a timely manner with the backend database, resulting in the patient's clinician not getting patient data tor one or two days. | Class II | Terminated | |
| Z-1375-2013 | QuietCare. Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. | Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Class II | Terminated | |
| 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. | Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product. | Class II | Terminated | |
| Z-0877-2013 | QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements. | Care Innovations detected a software anomaly: During the engineering investigation into the cause of why a Wander Alert was not generated, a defect in the implementation of the Wander and Night Motion ADLs was discovered. | Class II | Terminated | |
| Z-1703-2012 | 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. | On 7/29/11, the QuietCare production system experienced a partial outage from about 15:00 hours until 22:30. During the engineering investigation into the cause of the service disruption, it was discovered that some residents did not have the wander and night motion features properly activated, and alerts were not being transmitted. Failure to generate alerts in a timely manner could result in a | Terminated | ||
| Z-1615-2012 | 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. | The QuietCare production system experienced a partial outage on 7/29/11. As a result of the partial outage, some monitoring data about residents' movements was not processed in the production system, and alerts were therefore not sent to caregivers. The problem was identified and corrected and the unprocessed data was recovered and processed. However, because of the time lag in processing, a fe | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain