Nexalin KS02001

GUDID B788KS02001

Patient cable for transcranial electrical stimulation (TES)

NEXALIN TECHNOLOGY

Transcranial electrical stimulation system, continuous-current, professional

• Primary Device ID: B788KS02001
• NIH Device Record Key: db10f4da-bd45-4caa-b678-961779a28a18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexalin
• Version Model Number: KS02001
• Catalog Number: KS02001
• 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: 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
HIBCC	B788KS02001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024377

FDA Product Code

• JXK: Stimulator, Cranial Electrotherapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-08-07
• Device Publish Date: 2019-10-07

On-Brand Devices [Nexalin]

• B788KS02000: KS02000
• B788KS02001: Patient cable for transcranial electrical stimulation (TES)