REGULATORY COMPLIANCE
Important regulatory information about Nurochek™ by Headsafe™.
FDA 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).
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).
IMPORTANT SAFETY INFORMATION
Please Note:
- Nurochek™ is an aid to diagnosis, not a standalone diagnostic device. Clinical judgment remains essential.
- The device is cleared for use in patients ages 12-44. It is not cleared for pediatric populations under 12 years.
- Nurochek™ does not replace CT or MRI for ruling out structural brain injuries such as bleeds.
- Return-to-play decisions should involve comprehensive clinical evaluation, not just Nurochek™ results.
- The device should only be operated by trained clinical staff in accordance with the user manual.
For complete prescribing information, including contraindications, warnings, and precautions, please refer to the product labeling or contact Headsafe™ at regulatory@headsafe.com.