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

• 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