Panels › Physical Medicine › Product code IQA · Class 2
System, Environmental Control, Powered
Regulation 890.3725
0510(k)s in 12 months (24 all time)
2recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in IQA
| Company | 510(k)s | Recalls |
|---|---|---|
| Securitas Healthcare LLC | 0 | 10 |
| Intel-GE Care Innovations LLC | 0 | 4 |
| Prentke Romich Co. | 3 | 0 |
| Rehab Technology, Inc. | 3 | 0 |
| Apt Technology, Inc. | 2 | 0 |
| Baylor Biomedical Services | 2 | 0 |
| J. H. Emerson Co. | 2 | 0 |
| Stanley Security Solutions Inc | 0 | 2 |
| Ascom (US) Inc. | 0 | 1 |
| Hill-Rom, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Securitas Healthcare LLC Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3 Open, Classified |
IQA | None listed |
| Jan 8, 2026 | Securitas Healthcare LLC Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3 Open, Classified |
IQA | None listed |
| Nov 27, 2024 | Securitas Healthcare LLC Arial Server Software Versions 11.1.4 through 11.1.6, SKU 54305, in conjunction with the Arial Mobile Application or Arial Care Giver Application Open, Classified |
IQA | None listed |
| Jul 23, 2024 | Securitas Healthcare LLC Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station. Open, Classified |
IQA | None listed |
| Jul 23, 2024 | Securitas Healthcare LLC Arial Call Station, Model Numbers CSK200 and CSK200MR, is a wireless, battery-operated call device installed inside resident living areas to allow immediate staff response. Open, Classified |
IQA | None listed |
| May 31, 2024 | Securitas Healthcare LLC Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 and Apple iOS 17.5, a component of the Arial Emergency and Nurse Call System. Open, Classified |
IQA | None listed |
| Nov 3, 2023 | Securitas Healthcare LLC Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362; mobile patient alarm Open, Classified |
IQA | None listed |
| Nov 3, 2023 | Securitas Healthcare LLC Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm Open, Classified |
IQA | None listed |
| Nov 3, 2023 | Securitas Healthcare LLC Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm Open, Classified |
IQA | None listed |
| Mar 14, 2023 | Securitas Healthcare LLC Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system. Open, Classified |
IQA | None listed |
| Nov 17, 2021 | Stanley Security Solutions Inc Senior Living Arial Emergency and Nurse Call Systems Open, Classified |
IQA | None listed |
| Jun 14, 2019 | Stanley Security Solutions Inc STANLEY Healthcare Arial 54315 Network Manager Terminated |
IQA | None listed |
| Nov 2, 2018 | Ascom (US) Inc. Ascom Telligence Nurse Call System Open, Classified |
IQA | 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 |
| 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 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.