EYE-SYNC

GUDID 00860013612900

The NeuroSync EYE-SYNC device is a portable, fully enclosed eye tracking environment with two primary components: 1. Eye Tracker (head-mounted device) with eye tracking sensor and display 2. Android Tablet The eye tracker is a Pico Neo 3 Pro Eye with embedded sensors provided by Tobii Tech. It is mounted to the subject's face and held in place using a strap. The eye tracking sensor includes two cameras (one for each eye) to capture eye movement data. Eye gaze tracking is performed using a proprietary implementation of the pupil-corneal reaction method. The integrated display within the headset provides a binocular visual field and operates as part of the standalone VR system, running on Qualcomm Snapdragon XR2 hardware. The headset processes eye-tracking data internally and supports USB-C connectivity. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance.

NEUROSYNC INC.

Vision physiology/eye movement analysis system

• Primary Device ID: 00860013612900
• NIH Device Record Key: 05460b30-585c-40ec-8fc3-9b97e2e02cd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EYE-SYNC
• Version Model Number: X03
• Company DUNS: 966659307
• Company Name: NEUROSYNC 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: 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

Customer Support Contacts

• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health
• Phone: 8554558500
• Email: support@neurosync.health

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013612900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152915

FDA Product Code

• GWN: Nystagmograph

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: 2025-03-20
• Device Publish Date: 2025-03-12