INDICATIONS FOR USE
FDA-cleared regulatory information and clinical guidance for healthcare professionals using the Nurochek™-Pro System.
FDA 510(k) Clearance
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). This device is available by prescription only.
510(k) Number: K243426
Indication for Use
The Nurochek™-Pro System is intended for prescription use in healthcare facilities for subjects aged between 12 and 44 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.
The Nurochek™-Pro System is indicated for the generation of visual evoked potentials (VEP) and to acquire, transmit, display, and store electroencephalograms (EEG) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 12 and 44 years old who have sustained a potential head injury in the past 120 hours (5 days).
Clinical Use Context
- Prescription use in healthcare facilities only
- To be used by or under the supervision of qualified healthcare professionals
- As an aid to diagnosis, in conjunction with standard neurological assessment
- To provide objective, quantitative brain function data to support clinical judgment
- Not intended as a standalone diagnostic device
Patient Population
Age Range
12 to 44 years old
FDA-cleared for use in this age range
Time Window
Within 120 hours (5 days)
Of sustaining a potential head injury
Technology Indication
The Nurochek™-Pro System is indicated for:
VEP Generation
Generation of visual evoked potentials (VEP) to measure brain response to visual stimuli.
EEG Acquisition
Acquire, transmit, display, and store electroencephalograms (EEG) during VEP generation.
Signal Analysis
Analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects who have sustained a potential head injury in the past 120 hours (5 days).
Intended Settings
Emergency Departments
Hospital emergency rooms and trauma centers
Urgent Care Centers
Walk-in clinics and immediate care facilities
Sports Medicine Clinics
Athletic training rooms and sideline assessment
Neurology Practices
Outpatient neurology and concussion specialty clinics
Imaging Centers
Diagnostic imaging facilities
Contraindications & Precautions
Do Not Use Nurochek™-Pro If Patient Has:
- History of seizures or epilepsy
- Known photosensitive conditions
- Certain structural brain injuries or abnormalities
- Legal blindness or severe visual impairment
- Inability to follow visual stimulus instructions
Important Warnings
- !Nurochek™-Pro is an aid to diagnosis and should not replace comprehensive clinical evaluation
- !Results should be interpreted by qualified healthcare professionals in the context of the patient's complete clinical picture
- !A negative result does not rule out mTBI; clinical judgment remains paramount
- !Not cleared for use in ruling out intracranial hemorrhage or other structural brain injuries
- !Return-to-play and return-to-activity decisions should involve comprehensive clinical assessment
REGULATORY DOCUMENTATION
For complete regulatory documentation, including the full Instructions for Use (IFU) and 510(k) summary, please contact HeadSafe directly.
Healthcare professionals and facility administrators can request regulatory documentation packages for compliance review.
Contact HeadSafe™ for DocumentationQUESTIONS ABOUT CLINICAL USE?
Our clinical team is available to answer questions about Nurochek™-Pro's regulatory status, clinical integration, and appropriate use cases.