Wellness Products: does FDA require 510k for selling wellness products?

[Mangafanga]

Hello,

I am planning to sell wellness products in the US, these are fitness devices targeted towards encouraging healthy lifestyle. Do I need a 510k? If not, then what regulation of FDA do I need to follow to market my device as FDA approved?

In general, does FDA regulate wellness devices at all? I could not find much over the internet except for a FDA guidance on General wellness.

Regards

 

[ChrisM]

IIRC there is something about a device only needing FDA approval if it offers a "medical improvement" in the condition of the person using it. No doubt someone with more specific knowledge of the Regs will be along soon to quote the precise text, but anything that is just aimed at a person's lifestyle rather than their actual medical health is most likely not subject to FDA / 510(k) approval.

There may be other regulations and laws that apply, however.

 

[Mangafanga]

IIRC there is something about a device only needing FDA approval if it offers a "medical improvement" in the condition of the person using it. No doubt someone with more specific knowledge of the Regs will be along soon to quote the precise text, but anything that is just aimed at a person's lifestyle rather than their actual medical health is most likely not subject to FDA / 510(k) approval.

There may be other regulations and laws that apply, however.

Thanks for your response Chris. My device does not fit into the definition of Medical device, my intended use is only to "encourage" healthy lifestyle/fitness and I do not claim anything else (treat/diagnose/help, etc.)

 

[yodon]

@ChrisM is correct. See this guidance.