Company ยท US
Intel-GE Care Innovations LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2013. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2013 | K131585 | INTEL-GE CARE INNOVATIONS QUIETCARE Intel-Ge Care Innovations, LLC | KMI |
| Aug 9, 2013 | K130821 | INTEL-GE CARE INNOVATIONS CONNECT RCM Intel-Ge Care Innovations, LLC | DRG |
| Jun 4, 2013 | K130290 | MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE Intel-Ge Care Innovations, LLC | DRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2017 | Intel-GE Care Innovations LLC 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 patie Terminated |
OUG | None listed |
| May 24, 2013 | Intel-GE Care Innovations LLC QuietCare.
Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. Terminated |
IQA | None listed |
| May 24, 2013 | Intel-GE Care Innovations LLC QuietCare-Networked.
Intended for use in monitoring the environmental conditions and activity (motion) of an individual living in a senior housing community. Terminated |
IQA | None listed |
| Feb 23, 2013 | Intel-GE Care Innovations LLC QuietCare-Networked product, Facility Server/model: QC101601;
The QuietCare system is intended to detect and analyze residents' movements. Terminated |
KMI | None listed |
| Jun 5, 2012 | Intel-GE Care Innovations LLC 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 Terminated |
IQA | None listed |
| May 16, 2012 | Intel-GE Care Innovations LLC 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. QuietCa Terminated |
IQA | None listed |