NeuroEyeCoach

NeuroEyeCoach is a saccadic training program for those who have vision disorders caused by a stroke or brain injury. It is designed to address a patient’s difficulty with eye movement and…

Registry build 21.09.26

NeuroEyeCoach is a saccadic training program for those who have vision disorders caused by a stroke or brain injury. It is designed to address a patient’s difficulty with eye movement and the integration of visual information. The therapy re-trains the patient’s ability to scan the environment, re-integrate left and right vision, and make the most of their remaining visual field. NeuroeyeCoach is self-adaptive and adjusts the task difficulty to the patient’s deficit and stage of recovery while encouraging eye movement efficiency.

3manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NXR
Manufacturer City Province Registered as Device types
Wuxi Zontai Int’l Corporation Ltd. Wuxi Jiangsu Contract manufacturer 22
Shenzhen Kaiyan Medical Equipment Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
Beijing Mingren Shikang Technology Co., Ltd. Beijing Beijing Manufacturer 1

Record

Regulatory record for NeuroEyeCoach
Listed by Novavision, Inc., United States
FDA product code NXR
Device type Fixation, Vision Training, Binocular
Device class Class 1
Regulation 21 CFR 886.1290
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-07-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes

Catalogue Numbers

Catalogue numbers for NeuroEyeCoach
Catalogue number Size Status
NEC 2.00 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Fresnel Prism AND Lens Fresnel Prism & Lens Co. 2
Otus® Fixation, Vision Training, Binocular Edenlux Corp. 1
Brock String Gulden Ophthalmics 1

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