Disclaimer (USA)

Although the technology behind the new THERA WELLNESS® device has been evolving for over 40 years, its connection to health and wellness has not been established or demonstrated to the extent required by the U.S. Food and Drug Administration (FDA) for medical devices. The operation of the new THERA WELLNESS® device should not be intended or construed to diagnose, cure, mitigate, prevent, or treat any disease or medical condition. Instead, it is designed, along with a healthy diet and lifestyle, to support and promote energetic balance, enhance healthy function, vitality, and overall well-being.

The THERA WELLNESS® device has been designed and constructed with the intention to meet the non-binding recommendations set forth in docket number FDA-2014-N-1039: “General Wellness: Policy for Low-Risk Devices; Guidance for Industry and Food and Drug Administration Staff” issued on September 27, 2019.

International Notice: In other countries, bioresonance devices, including the THERA WELLNESS® device, have been approved as medical devices and are recognized for treating certain health conditions. However, such approvals do not apply within the United States, where the device is intended solely for wellness purposes as described above.