Panels › Physical Medicine › Product code ILQ · Class 2
System, Communication, Powered
Regulation 890.3710
0510(k)s in 12 months (38 all time)
2recalls in 12 months (19 all time)
4recalls that name a 510(k)
Top companies in ILQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Lifeline Systems, Inc. | 1 | 3 |
| Prentke Romich Co. | 4 | 0 |
| Zygo Industries, Inc. | 4 | 0 |
| Baxter Healthcare Corporation | 0 | 3 |
| Med Labs, Inc. | 3 | 0 |
| Possum, Inc. | 3 | 0 |
| Tobii Dynavox Llc | 0 | 3 |
| Baylor Biomedical Services | 2 | 0 |
| Companion Products Intl. | 2 | 0 |
| Dynavox Systems Llc | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Tobii Dynavox Llc TD Navio Maxi Speech Generating Device
Model/Catalog Number: 1000799 Open, Classified |
ILQ | None listed |
| Aug 14, 2026 | Tobii Dynavox Llc TD Navio Midi Speech Generating Device
Model/Catalog Number: 1000798 Open, Classified |
ILQ | None listed |
| Apr 18, 2023 | Tobii Dynavox Llc Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities.
Catalog #: 750567 Open, Classified |
ILQ | None listed |
| May 31, 2022 | Baxter Healthcare Corporation NaviCare Nurse Call/Voalte Nurse Call Open, Classified |
ILQ | None listed |
| Apr 13, 2022 | Baxter Healthcare Corporation Voalte Nurse Call
System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls. Terminated |
ILQ | None listed |
| Apr 13, 2022 | Baxter Healthcare Corporation NaviCare Nurse Call
System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls. Terminated |
ILQ | None listed |
| Mar 28, 2022 | Medminder Systems, Inc. MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center. Terminated |
ILQ | None listed |
| Oct 14, 2021 | Hill-Rom Inc. These are communication systems, labeled as:
a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9
b. Voalte Nurse Call, Part Number 4.0
*Product was rebranded from NaviCare to Voalte in 2020 Terminated |
ILQ | None listed |
| Oct 11, 2021 | Forbes Rehab Services Inc Affected components are limited to the Monoprice charging cable (Product # 4867) and 24W iClever Boost Cube charging brick components for the SoundPOD Bluetooth Speaker accessory to the ProSlate Speec Open, Classified |
ILQ | None listed |
| Dec 14, 2017 | Dynavox Systems Llc Dynavox T15 Speech Generating Device ( including Batteries) Terminated |
ILQ | None listed |
| Dec 14, 2017 | Dynavox Systems Llc Dynavox T10 Speech Generating Device ( including Batteries) Terminated |
ILQ | None listed |
| Nov 13, 2017 | Lifeline Systems Company HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. Terminated |
ILQ | K914103 |
| Jun 22, 2016 | Stanley Security Solutions Inc Arial Wireless Water-Resistant Call Pendant
The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independe Terminated |
ILQ | None listed |
| Oct 1, 2015 | Lifeline Systems, Incorporated Philips GoSafe Mobile Help Button; 7000MHB.
Personal Emergency Response System. Terminated |
ILQ | K914103 |
| Jul 6, 2015 | Lifeline Systems, Incorporated Philips GoSafe Communicator 7000L
Personal emergency response system. Terminated |
ILQ | K914103 |
| Sep 17, 2013 | Rauland-Borg Corp Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, tr Terminated |
ILQ | None listed |
| Feb 1, 2013 | Tobii Assistive Technology, Inc. P10 Tobii battery box (product number 510410)
Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control syste Terminated |
ILQ | None listed |
| Jun 29, 2011 | Tobii Assistive Technology, Inc. Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices.
Communication device for the impaired and functions as a speech Terminated |
ILQ | None listed |
| Nov 25, 2009 | Philips Lifeline Inc Philips Lifeline Personal Help Button Pendant Classic and Slimline Style. Terminated |
ILQ | K914103 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.