Nexalin ADI

GUDID 00860008546005

Single-use Electrode set for the Nexalin ADI/AI Console

NEXALIN TECHNOLOGY

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00860008546005
• NIH Device Record Key: 25b7dde4-0746-44f8-ac10-ccfcd93f549b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexalin ADI
• Version Model Number: DXD 0080
• Company DUNS: 091477825
• Company Name: NEXALIN TECHNOLOGY
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature and out of direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature and out of direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008546005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024377

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2026-03-24
• Device Publish Date: 2026-03-16

Devices Manufactured by NEXALIN TECHNOLOGY

• 00860008546005 - Nexalin ADI: 2026-03-24Single-use Electrode set for the Nexalin ADI/AI Console
• 00860008546005 - Nexalin ADI: 2026-03-24 Single-use Electrode set for the Nexalin ADI/AI Console
• B788KS02001 - Nexalin: 2024-08-07 Patient cable for transcranial electrical stimulation (TES)
• B788KS02000 - Nexalin: 2019-10-09