Duns Number:080143399
Device Description: The NuEye™ Tracking System is setting a new standard for eye gaze systems. Compatible with The NuEye™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400, Accent 1200* and Accent 1000, now you can access the full communication & computing power with just your eyes!Note: Photos show NuEye™ Tracking System module only and attached to an Accent 1400.The NuEye Tracking System attaches quickly to the Accent 1400, Accent 1200 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech.Developed in partnership with SensoMotoric Instruments GmbH (SMI) of Germany, a global leader in eye tracking technology for more than 20 years. NuEye is ideal for children and adults who need hands-free and switch-free device access.
Catalog Number
-
Brand Name
NuEye™
Version/Model Number
NE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILQ
Product Code Name
System, Communication, Powered
Public Device Record Key
ddb1e001-0dfb-4d37-bd53-e06371d70e2f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 198 |