Invoy’s Wellness Program
Invoy’s device has not been reviewed by the U.S. Food and Drug Administration (FDA). This is because Invoy’s device fits within FDA’s definition of a wellness product.
Visit the website for FDA’s guidance for wellness devices.
According to the FDA, a general wellness product is one that:
For the purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
The products in the second category meet the regulatory definition of a medical device, but FDA chooses not to regulate them because they are low risk products whose operating principles are well accepted.
Invoy Provides Wellness (not Medical) Advice
Invoy provides you with a team of analysts who are trained to connect the dots between your data and actions. The analyst team gets trained on how to interpret breath acetone levels and on a wide range of different diet programs. We are really good at motivating people to stick with a nutrition program and to help reach their weight management goals.
Our analyst team is not qualified to provide medical advice. This means that if you have a medical concern, it is important to talk with your physician before joining. It is also a great idea to talk with your physician during your journey.
If you have specific preferences, e.g., that you want to be on Diet A or Diet B, or you cannot eat Food A or Food B, we can absolutely work with you to account for your preferences.