Compliance for UniWhale

UniWhale and SiriuXense products have met and achieved certifications for the following U.S. federal and California regulatory standards:

 

1. FCC (Federal Communications Commission) Regulations for Network Communication Devices

• Scope:
   

  • UniWhale’s wireless communication technologies (Bluetooth 5.1 BLE, Wi-Fi 11b/g/n) are fully certified under FCC Part 15 regulations for low-power radio frequency devices.

• Achievements:
   

  • RF Testing: UniWhale has undergone rigorous radio frequency emission testing, ensuring compliance with FCC standards for power levels and interference mitigation.

  • Labeling and Documentation: All products include FCC compliance labels and provide clear user guidelines to prevent interference.

  • Certification: FCC certification was successfully completed through an FCC-accredited laboratory, confirming the product’s compliance for market distribution.

 

2. U.S. Consumer Product Safety Commission (CPSC) CPC Certification for Children's Products

• Scope:
   

  • UniWhale has obtained the Children’s Product Certificate (CPC), verifying compliance with U.S. safety standards for wearable devices intended for children.

• Achievements:
   

  • Third-Party Testing: Safety tests have been conducted and certified by a CPSC-accredited laboratory.

  • Material Safety: UniWhale uses non-toxic, food-grade silicone materials that meet ASTM F963 toy safety standards.

  • Labeling: Products include clear, age-appropriate safety warnings and detailed usage instructions.

  • Traceability: Manufacturer information and production batch identifiers are provided to ensure transparency and efficient recall management, if necessary.

 

3. ISO 60601-1 Electrical Safety Standards

• Scope:
   

  • UniWhale complies with ISO 60601-1 standards, ensuring electrical safety for devices that interact with the human body.

• Achievements:
   

  • Leakage Current Testing: The device passed leakage current tests, ensuring safety under both normal and single-fault conditions.

  • Mechanical Strength: The product demonstrated durability and reliability during mechanical stress testing.

  • Environmental Adaptability: Devices function reliably across varying temperature, humidity, and vibration conditions.

 

4. UL 4200A Safety Certification for Rechargeable Lithium Batteries

• Scope:
   

  • The rechargeable lithium battery within UniWhale has been certified under UL 4200A safety standards.

• Achievements:
   

  • Battery Design: The lithium battery cells meet UL 1642 standards and include protections against overcharge, over-discharge, overcurrent, and short circuits.

  • Thermal and Overload Testing: The battery passed high-temperature and overload safety tests, ensuring secure operation.

  • Battery Life Testing: The device demonstrated compliance with charging and discharging cycle longevity requirements.

  • Packaging and Instructions: Safety guidelines for battery handling and charging are included, ensuring proper user awareness and safe usage.

 

5. Additional U.S. and California Compliance

• Data Privacy and Protection:
   

  • UniWhale meets California Consumer Privacy Act (CCPA) and California Online Privacy Protection Act (CalOPPA) requirements, offering:

    • Transparent privacy policies.

    • User rights for data access, deletion, and opt-out options.

    • Mechanisms for managing children’s data in compliance with the Children’s Online Privacy Protection Act (COPPA).

• Health Insurance Portability and Accountability Act (HIPAA):
   

  • UniWhale ensures secure handling of health-related data, meeting HIPAA requirements for products used in healthcare environments.

• IoT Cybersecurity:
   

  • UniWhale adheres to IoT Cybersecurity Improvement Act standards by incorporating strong authentication, encryption, and regular software updates.

• California Proposition 65:
   

  • All materials used in UniWhale are certified as free from harmful chemicals, ensuring safe use for children and compliance with California Proposition 65.

 

6. U.S. Consumer Product Safety and Medical Disclaimer

UniWhale has been developed and certified as an auxiliary health monitoring device and is not classified as a medical device. While it provides real-time health data and alerts, it is not intended for diagnosis or treatment of medical conditions. Users and caregivers remain responsible for assessing the health and safety of individuals based on the provided data.