Nexalin KS02000

GUDID B788KS02000

NEXALIN TECHNOLOGY

Transcranial electrical stimulation system, continuous-current

• Primary Device ID: B788KS02000
• NIH Device Record Key: 32ddd299-7f33-4985-be65-d9c643ce0906
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nexalin
• Version Model Number: KS02000
• Catalog Number: KS02000
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B788KS02000 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-09
• Device Publish Date: 2019-10-01

On-Brand Devices [Nexalin]

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