Regulatory & Compliance

Oxyzen.ai

Wellness · Privacy · Security · Responsible AI

Last updated: December 2025

Oxyzen is committed to operating responsibly, transparently, and in alignment with applicable European Union requirements for consumer wellness technology. This page explains our regulatory positioning, privacy practices, AI transparency approach, product safety standards, and cybersecurity posture.

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1. Our Product Positioning

Wellness Insights (Non-Medical Use)

Oxyzen provides AI-powered wellness insights designed to support healthy lifestyle awareness, including sleep patterns, activity balance, readiness trends, and habit guidance.

Oxyzen is not a medical device.

It is not intended to diagnose, treat, cure, or prevent any disease.

Oxyzen does not replace professional medical advice. Users with health concerns should consult a qualified healthcare professional.

This positioning applies across our website, mobile applications, marketing materials, packaging, and user interfaces.

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2. AI Transparency & Responsible Use

Oxyzen uses artificial intelligence to analyze wellness data and present insights in a clear and understandable way.

Our approach to AI is guided by transparency, user control, and responsibility:

• AI-generated insights are designed for wellness and lifestyle guidance only

• We clearly communicate that insights are informational, not clinical

• Users remain in full control and may ignore, disable, or discontinue AI-based features

• We avoid automated decision-making with legal or medical effects

• We monitor performance and user feedback to improve reliability and clarity

Oxyzen’s AI systems are designed in alignment with applicable EU AI transparency and governance principles for limited-risk consumer applications.

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3. Privacy & Data Protection (GDPR)

Our Commitment to Privacy

We respect user privacy and apply data-protection-by-design principles throughout our systems.

Oxyzen processes wellness and biometric-related data only to deliver features requested by users and operates in alignment with the EU General Data Protection Regulation (GDPR).

Key Privacy Practices

• Explicit user consent is obtained where required, particularly for wellness and biometric data

• Data collection is limited to what is necessary for product functionality

• Data is not sold to third parties

• Retention periods are defined and enforced

• Users may request access, correction, portability, or deletion of their data

User Rights

Users may exercise their data-protection rights by contacting us or using in-app controls where available.

Related documents:

• [Privacy Policy]

• [Cookie Policy]

• [Data Access & Deletion Request]

4. Product Safety & EU Market Readiness

Oxyzen is designed as a consumer wellness wearable and follows applicable EU consumer product safety expectations.

Product Safety Approach

• Risk-based product design and testing

• Device traceability and batch identification

• Clear user instructions and safety information

• Internal processes for incident reporting and corrective action

Wireless & Connectivity

Oxyzen devices use wireless communication technologies developed to align with applicable EU radio and electromagnetic compatibility requirements.

We maintain technical documentation and testing programs appropriate for consumer electronic products placed on the EU market.

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5. Cybersecurity & Secure-by-Design

Oxyzen treats cybersecurity as a core product requirement.

Our security approach includes:

• Secure communication between device, app, and backend systems

• Access controls and authentication protections

• Monitoring and logging to detect abnormal activity

• Secure update mechanisms where applicable

• Internal procedures for identifying and addressing vulnerabilities

Vulnerability Reporting

We encourage responsible disclosure of security issues.

Security contact:

security@oxyzen.ai

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6. Environmental & Sustainability Considerations

We work with manufacturing and logistics partners to support responsible handling of electronic components and batteries where applicable.

Guidance on safe use, charging, and disposal is provided to users as part of our product documentation.

7. Compliance Status Overview

Oxyzen continuously reviews regulatory developments and updates internal processes as requirements evolve.

8. Contact & Regulatory Inquiries

For questions related to compliance, privacy, or security:

• General support: support@oxyzen.ai

• Privacy & data protection: privacy@oxyzen.ai

• Security disclosures: security@oxyzen.ai

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