NeuroEyeCoach

Primary DI
00860010599716
Brand
NeuroEyeCoach
Company
Novavision, Inc.
Model
NEC 2.00
Device description
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.
Published
2023-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NXRFixation, Vision Training, Binocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXRFixation, Vision Training, BinocularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010599716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010599716008600105997168600105997160860010599716

GMDN Terms#

Term, Definition table
TermDefinition
Vision training softwareA patient-interactive software package intended to use visual images (e.g., Gabor patch) to help improve vision based on noninvasive perceptual learning therapy (neuro-vision therapy), typically in patients with amblyopia, or who use corrective eyewear, or following ophthalmic surgery. It is intended to be used in the home under clinical guidance.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078373323
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010599709Vision Restoration TherapyVRT 7.02023-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809765430006OTUS® Fixation, Vision Training, BinocularEDENLUX Corp.NXR2025-07-07
B091151330Brock StringGulden Ophthalmics Inc.NXR2023-07-05
00850029104650FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2023-02-05
00850029104414FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2021-03-29
08500291040492FRESNEL PRISM AND LENSFresnel Prism & Lens CompanyNXR2021-03-29