PranaQ

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

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