[Holly]

Hi @AmieSmirthwaite I would definitely take a look at FDA’s guidance on general wellness devices (here’s the link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices) to ensure that it truly meetings the definition of a general wellness product. There has been a lot of activity with devices in this space getting warning letters from FDA because its their position that they did not meet the definition! As warning letters are public, they can create huge issues for investors, stocks, etc (even if the issue ultimately gets resolved with FDA).

fda.gov

General Wellness: Policy for Low Risk Devices - Guidance

This guidance provides clarity on FDA's compliance policy for low risk products that promote a healthy lifestyle (general wellness products).