Terms of Use and Disclaimer

Definitions

For purposes of this Disclaimer:

• "End User" means any individual who directly uses the Hardware, Platform or Services
• "Hardware" means Psyray's physical devices
• "Platform" means Psyray's software platform
• "Services" means all services provided by Psyray in connection with the Hardware and Platform
• "Results" means any outputs, insights, or information generated by the Hardware, Platform, or Services

1. Intended Use

Psyray provides insights for self-reflection, personal awareness, and general wellbeing purposes only. 
The Hardware, Platform and Services are designed for informational and general wellness purposes only. All Results should be viewed as one source of information among many and should never be the sole basis for any decision related to health, mental health, or wellbeing.

2. Not a Medical Device or Service

The Hardware, Platform and Services are NOT medical devices.
Psyray does NOT provide medical, psychological, psychiatric, therapeutic, diagnostic, or treatment services of any kind. 

The Hardware, Platform and Services:

• are not intended to diagnose, treat, cure, or prevent any disease or medical condition;
• are not a substitute for professional medical, psychological, or psychiatric advice, diagnosis, or treatment;
• should not be used to make medical or health-related decisions;
• should not be relied upon in emergency situations or for urgent health matters.

3. No Professional Healthcare Relationship

Use of the Hardware, Platform and Services does not create any therapist-client, doctor-patient, psychologist-patient, or any other professional healthcare relationship between Psyray and any End User.

Psyray is not a licensed healthcare provider or healthcare institution in any jurisdiction.

4. Important End User Warnings

End Users must be informed that they should:

• consult with qualified healthcare professionals before making any decisions based on Results;
• seek immediate professional medical or psychiatric help if experiencing any mental health crisis, suicidal thoughts, or medical emergency;
• not disregard, avoid, or delay obtaining medical or mental health advice from qualified professionals because of any Results.

5. Contraindications

The Hardware, Platform and Services should NOT be used by individuals who are:

• under 18 years of age;
• diagnosed with a mental health condition, unless expressly approved by their treating healthcare provider;
• in a crisis situation or experiencing acute mental health symptoms;
• seeking a substitute for prescribed treatment or medication.

6. No Guarantees Regarding Results

Psyray makes no representations, warranties, or guarantees regarding:

• the accuracy, reliability, completeness, or timeliness of any Results;
• the suitability of any Results for any particular purpose;
• any improvement in wellbeing, mental health, or any other outcome;
• the performance or efficacy of any recommendations or insights provided.

7. Regulatory Status

Not Approved as Medical Devices

The Hardware, Platform and Services have not been evaluated or approved by:

• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• National competent authorities in EU Member States
• Any other medical regulatory authority

Not Medical Devices Under Applicable Law

The Hardware is not classified as a medical device under:

• Federal Food, Drug, and Cosmetic Act (United States)
• EU Medical Device Regulation (MDR 2017/745)
• UK Medical Devices Regulations 2002
• Any other applicable medical device regulations

The Platform and Services are not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or any other medical condition.

Data Protection Status

United States: Psyray is not a covered entity under the Health Insurance Portability and Accountability Act (HIPAA). The Hardware, Platform and Services are not HIPAA-compliant healthcare products.

European Union: Psyray is not a healthcare provider or healthcare institution as defined under EU or Member State healthcare legislation.

8. Prohibited Claims

The Hardware, Platform and Services must not be marketed, advertised, or represented as:

• medical devices;
• diagnostic tools;
• therapeutic or treatment devices;
• substitutes for professional medical or mental health care;
• FDA-approved, EMA-approved, or approved by any medical regulatory authority;
• effective for treating, curing, or preventing any medical or mental health condition.

9. Not the Practice of Medicine

No aspect of the Hardware, Platform or Services constitutes the practice of medicine, psychology, counseling, or any other healthcare profession. Psyray does not provide services requiring professional healthcare licensing in any jurisdiction.

Important Notes for Prospective Partners

Partnership Requirements

Distribution Partners and Resellers will be required to:

• provide appropriate disclaimers and warnings to End Users;
• comply with all applicable laws regarding the sale and distribution of wellness products;
• refrain from making medical or health-related claims;
• ensure marketing materials are consistent with these limitations.

Full Terms Available Upon Request

This disclaimer provides an overview of product limitations for informational purposes. Complete contractual terms, partner obligations, liability provisions, and other business terms will be addressed in formal partnership agreements.