Medical & General Wellness Disclaimer
Last Updated: October 16, 2026 • Application: Mentius
1. Non-Medical Software Declaration (SaMD Isolation)
Mentius is engineered and operated strictly as a General Wellness, Lifestyle, and Cognitive Fitness Software Application.
- Not a Medical Device (SaMD): Mentius is NOT a Software as a Medical Device (SaMD) under the United States FDA "General Wellness: Policy for Low Risk Devices" (2019), the European Union Medical Device Regulation (EU MDR 2017/745, Annex VIII Rule 11), or equivalent international health authority standards.
- No Clinical Diagnosis or Treatment: The App does not diagnose, treat, cure, or screen for any clinical illness, anxiety disorder, depression, or psychiatric condition.
- No Prescription or Clinical Advice: No test score, cognitive rating, audio session, or habit pacing metric constitutes medical advice, psychiatric evaluation, or clinical prescription.
🚨 Emergency & Crisis Hotline Notice
Mentius does NOT provide crisis intervention, emergency dispatch, or suicide prevention monitoring.
If you are experiencing severe emotional distress, overwhelming crisis, thoughts of self-harm, or are in physical danger, please cease using the App immediately and reach out to free, confidential emergency hotlines:
- United States & Canada: Call or text 988 (Suicide & Crisis Lifeline) or dial 911
- United Kingdom: Call 111 or dial 999
- European Union: Call 112 (Universal Emergency Services)
- International Resources: findahelpline.com