Vision Restoration Therapy

GUDID 00860010599709

VRT-or Vision Restoration Therapy- is a computer-based light stimulation therapy that can be performed at the patient's home.

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: 00860010599709
• NIH Device Record Key: 2d57b0ee-0cac-4851-9762-696a39adddf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vision Restoration Therapy
• Version Model Number: VRT 7.0
• Company DUNS: 078373323
• Company Name: Novavision, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010599709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023623

FDA Product Code

• HPT: Perimeter, Automatic, Ac-Powered

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