OculoMotor Technologies

GUDID 00860012940608

Virtual Eye Rotation Vision Exercises for Convergence Insufficiency Therapy

Oculomotor Technologies Inc.

Virtual-display routine exercise software

• Primary Device ID: 00860012940608
• NIH Device Record Key: 2a92118f-2bda-4936-b651-a84e9b6ce1fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OculoMotor Technologies
• Version Model Number: VERVE
• Company DUNS: 081121764
• Company Name: Oculomotor Technologies 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: true
• Serial Number: true
• 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	00860012940608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232930

FDA Product Code

• SBN: Digital Therapy Device For Convergence Insufficiency

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: 2025-02-05
• Device Publish Date: 2025-01-28