Compliance & Safety Standards
PranaQ is committed to ensuring the highest standards of safety, reliability, and performance. Our device has undergone rigorous testing and complies with internationally recognized medical device regulations.
Performance & Clinical Validation
TipTraQ meets rigorous clinical and regulatory performance standards, ensuring accurate and reliable home-based sleep apnea testing.
- FDA 510(k) Clearance: TipTraQ is FDA-cleared for use in the USA (#K243268)
- ISO 80601-2-61: Pulse oximeter performance testing
Regulatory & Medical Safety Standards
TipTraQ is designed for safe use in clinical and home environments, complying with international medical device safety regulations.
- IEC 60601-1: General safety and essential performance for medical devices
- IEC 60601-1-2: Electromagnetic compatibility (EMC) testing
- IEC 60601-1-11: Safety requirements for home-use medical devices
- FCC Part 15: Electromagnetic interference (EMI) compliance
Patient Safety & Usability
To ensure patient comfort and safe use in home-based diagnostics, TipTraQ has been tested for biocompatibility and usability.
- ISO 10993-5: Cytotoxicity
- ISO 10993-10: Skin sensitization
- ISO 10993-23: Skin irritation
- IEC 62366: Medical device usability engineering
Data Security & Cybersecurity Compliance
Protecting patient health data is a priority in digital health solutions, ensuring compliance with security and privacy standards.
- HIPAA Compliance: Secure patient data handling
- NIST SP 800-115: Security assessment and penetration testing
- OWASP IoT Security Testing: Protection against cyber threats in connected devices
Reliability & Durability
TipTraQ is designed for long-term, consistent performance in home settings and tested under various environmental conditions.
- IEC 60601-4-2: Electromagnetic immunity for medical devices
- IP45 Certification: Protection against solid objects and water ingress
- Accelerated Aging Test: Simulated aging for long-term reliability
- Drop Testing: Ensures durability against impact
- Storage Testing: Validated for extreme environmental conditions:
- High humidity & high temperature
- High humidity & low temperature
- Low humidity & high temperature
