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.

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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.

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‍Storage and Handling

Keep the pods sealed in its foil packaging until right before your daily breath test.

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Check the Expiration Date

Do not use pods past the expiration date. We recommend using a fresh, new pod every morning to ensure you get the best insights from your breath test.

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Cautions

Single-Use Only. Discard the pod after each breath test. Do not keep used pods.

The pods contain chemicals that should not be ingested or touched. The pods also contain small parts that can pose a choking hazard. Keep out of reach of children and pets.

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Chemistry Composition

The daily wellness pods are primarily comprised of silica gel, methanol, and glycerol. For more information, please see the safety data sheets.

Download Invoy’s Safety Data Sheet on Pod Chemistry (Acetone Beads).

Download Invoy’s Safety Data Sheet on Pod Chemistry (Developer Solution).