Nurochek-Pro System
A portable visual evoked potential (VEP) / EEG system, used as an aid in the assessment of mild traumatic brain injury (mTBI) alongside standard neurological assessment.
The Nurochek-Pro System is a portable headset that generates visual evoked potentials (VEP) and acquires, transmits, displays and stores the resulting electroencephalogram (EEG).
It is intended for prescription use in healthcare facilities by healthcare professionals, as an aid in the assessment of mild traumatic brain injury (mTBI) in conjunction with standard neurological assessment. The system comprises a wearable headset, the Nurochek-Pro Software Application, and the Nurochek-Pro Server.
Illustrative product renders of the Nurochek-Pro headset, depicted accurately and within the certified intended purpose. Exploded views are provided for technical familiarisation.
The Nurochek-Pro System is an adjunct to, not a replacement for, standard clinical and neurological assessment.
Outputs inform, and are interpreted alongside, standard neurological assessment — not used as a standalone diagnosis.
Generation of visual evoked potentials with EEG acquisition, display and storage.
Prescription use in healthcare facilities by healthcare professionals.
Headsafe MFG Pty Ltd operates a Quality Management System certified as conforming to ISO 13485:2016, with MDSAP coverage. The Nurochek™-Pro System has received FDA 510(k) clearance as a Class II medical device for the aid in diagnosis of mild traumatic brain injury (mTBI) (510(k) Number: K243426). See Indications for Use for the cleared wording and current regulatory status by market.