FDA.reportPublic FDA data

Nurochek-Pro Headset

Primary DI
09357225001017
Brand
Nurochek-Pro Headset
Company
HEADSAFE MFG PTY LTD
Model
Nurochek-Pro Headset Assembly (HS03-267)
Catalog number
HS03-267
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.
Published
2025-12-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMCReduced- Montage Standard Electroencephalograph
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2
PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243426000Nurochek-Pro SystemHeadsafe Mfg Pty, Ltd.2025-03-27PIW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09357225001017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09357225001017093572250010179357225001017

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential graphic recording systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure620 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61413133492support@team.headsafe.com

Regulatory Flags#

DUNS number
748905226
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09357225002014Nurochek-Pro Headset Nurochek-Pro Headset Assembly (HS03-267)HS03-2672026-03-18
09357225000041Nurochek-ProNurochek-Pro Kit (HS03-369) rev 2HS03-3692026-01-23
09357225000034Nurochek-ProNurochek-Pro Kit (HS03-369) rev 1HS03-3692025-12-15
09357225002021Nurochek-Pro Application Nurochek-Pro Application (HS03-303)2025-12-15
09357225002038Nurochek-Pro ServerNurochek-Pro Server (HS03-304)HS03-3042025-12-15
09357225003028Nurochek-Pro Soft Sensor KitNurochek-Pro Soft Sensor Kit (HS03-313)HS03-3132025-12-15
09357225006029Nurochek-Pro Saline SolutionSaline Solution Bottle Assembly (HS03-368)HS03-3682025-12-15

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