NuEye™

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 &…

Registry build 21.09.26

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.

1manufacturer
1catalogue number
4510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code ILQ
Manufacturer City Province Registered as Device types
Shenzhen Contin Medical Device Co., Ltd. Shenzhen Guangdong Contract manufacturer 3

Record

Regulatory record for NuEye™
Listed by Prentke Romich Co., United States
FDA product code ILQ
Device type System, Communication, Powered
Device class Class 2
Regulation 21 CFR 890.3710
Establishment Manufacturer
Premarket notification Exempt
Record published 2016-09-24
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Label carries serial number
Storage Handling environment humidity up to 95 % RH; Storage environment temperature -20 to 50 °C; Handling environment temperature 0 to 45 °C
Sizes Weight 0.29 lb

Catalogue Numbers

Catalogue numbers for NuEye™
Catalogue number Size Status
NE Weight 0.29 lb In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
GEN4 Direct Access Curbell Medical Products, Inc. 1,343
GEN4 Interactive Curbell Medical Products, Inc. 1,005
GEN4 Plus, Direct Access Curbell Medical Products, Inc. 599
Responder 5, Interactive Curbell Medical Products, Inc. 573
Series 8 Anacom MedTek Anacom Medtek 519
Series 7 Anacom MedTek Anacom Medtek 312
GEN4 Plus, Responder 5, Enhanced Curbell Medical Products, Inc. 112
Responder 5, Enhanced Curbell Medical Products, Inc. 108
Tobii Dynavox Tobii Dynavox LLC 44
Nova Chat Prentke Romich Co. 44
GEN4 Plus, Responder 5, Standard Curbell Medical Products, Inc. 33
Saltillo Prentke Romich Co. 27

Showing 12 of 1,439. All products under System, Communication, Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K925387 1993-03-29
K925527 1993-03-22
K914259 1992-02-27
K902206 1990-05-29

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer