Nurochek-Pro Headset

Basic Information

• Brand Name: Nurochek-Pro Headset
• Primary DI: 09357225001017
• Version / Model: Nurochek-Pro Headset Assembly (HS03-267)
• Catalog Number: HS03-267
• Company Name: HEADSAFE MFG PTY LTD
• Labeler DUNS: 748905226
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-15
• Public Version: 2
• Public Version Date: 2026-03-18
• Public Version Status: Update
• Public Device Record Key: d1822fe5-3a2e-4bd1-9f54-ef953b3334c2
• Distribution End Date: 2026-03-17

Device Description

The Nurochek-Pro System is a medical device that consist of a headset that evokes and records steady-state visual-evoked potentials (SSVEP) via electroencephalography (EEG). The Nurochek-Pro headset communicates to a computer via an isolated USB-A connection, of which allows for user control of the device via a custom software Application (App). The App communicates with a cloud-based Server that stores and processes Nurochek data using a proprietary classification algorithm. The product requires internet connection to login to the application and process data.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	882.1400	2
PIW	Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid	Neurology	882.1450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11614	Evoked-potential graphic recording system	An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09357225001017	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K243426	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 620 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius