Data / Medical devices / System, Communication, Powered
System, Communication, Powered (ILQ): 42 FDA-registered makers in 10 countries
42 establishments in 10 countries are registered with the FDA to make System, Communication, Powered (product code ILQ, Class 2, 21 CFR 890.3710). 0 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 38 510(k) clearances under this code, the latest on January 18, 2017, and lists 16 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ILQ
- Device class
- 2
- Regulation
- 890.3710
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 31 |
| Taiwan | 3 |
| Sweden | 1 |
| Israel | 1 |
| Norway | 1 |
| Germany | 1 |
| Spain | 1 |
| Belgium | 1 |
| United Kingdom | 1 |
| China | 1 |
Makers of System, Communication, Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ablenet, Inc. | Roseville, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aionex, Inc. | Madison, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anacom General Corporation | Anaheim, CA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Austco Marketing & Service (usa) Ltd. | Irving, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Befitting You, LLC | Commerce Twp, MI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Control Bionics Inc. | Milford, OH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crest Electronics Inc. | Dassel, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curbell Medical Products, Inc. | Orchard Park, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DYNAVOX Group AB | Stockholm, Sweden | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eyefree Assisting Communication Ltd | Tel Aviv, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eyegaze Inc. | Fairfax, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eyetech Digital Systems | Tempe, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forbes Rehab Services Inc. | Mansfield, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Grasp AS | OS Hordaland, Norway | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hasomed GMBH | Magdeburg Saxony-Anhalt, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hatchmed Corporation | Kent, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hill-Rom, Inc. | Raleigh, NC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Intego Software, LLC D/B/A Critical Alert | Jacksonville, FL, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Irisbond Crowdbonding, S.L. | Donostia San Sebastian Guipuzcoa, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabbla | Gent Oost-Vlaanderen, Belgium | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jeron Electronic Systems Inc | Niles, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KESTRA Medical Technologies, Inc. | Kirkland, WA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lingraphicare America, Inc. | Princeton, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med Labs, Inc. | Goleta, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MedMinder Systems, Inc. | Norwood, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| New V-Key Technology Co., Ltd. | New Taipei City, Taipei, Taiwan | Contract manufacturer, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Healthcare Inc. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Onyx Healthcare Usa, Inc. | Orange, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prentke Romich Company | Wooster, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Proxtalker.com LLC | Waterbury, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R & D Batteries, Inc. | Burnsville, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RCS Management Corporation | Surprise, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reliance Mobility LLC | Columbia, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| S-Comm, Inc. | Raytown, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shelton Technologies And Resources LLC | Lakeland, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartbox Assistive Technology Inc | Lower Burrell, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartbox Assistive Technology Ltd | Malvern Worcestershire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartbox Us | Cedar Falls, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Contin Medical Device Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taiwan Serpro Corporation | Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tobii Dynavox LLC | Coraopolis, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov |
Updated January 18, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.