Disclaimer: 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 Federal Drug Administration (FDA) for medical devices. 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 but rather, along with a healthy diet and lifestyle, to support and promote energetic balance and enhance healthy function, vitality and wellbeing. 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 September 27, 2019
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