NeuroEyeCoach

GUDID 00860010599716

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.

Novavision, Inc.

Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software Vision training software

• Primary Device ID: 00860010599716
• NIH Device Record Key: 66966ec8-5720-4646-9a59-af336f6abffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeuroEyeCoach
• Version Model Number: NEC 2.00
• Company DUNS: 078373323
• Company Name: Novavision, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010599716 [Primary]

FDA Product Code

• NXR: Fixation, Vision Training, Binocular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-11
• Device Publish Date: 2023-07-03

Devices Manufactured by Novavision, Inc.

• 00860010599709 - Vision Restoration Therapy: 2023-07-11 VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.
• 00860010599716 - NeuroEyeCoach: 2023-07-11NeuroEyeCoach 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.
• 00860010599716 - NeuroEyeCoach: 2023-07-11 NeuroEyeCoach is a saccadic training program for those who have vision disorders caused by a stroke or brain injury. It is desi