Navigating the Landscape of General Wellness Devices

General wellness devices are reshaping personal health with fitness trackers, meditation apps, and sleep monitors. Under the FD&C Act, general wellness devices are products designed to promote a healthy lifestyle and are not intended to diagnose, treat, cure, or prevent any disease.

What Qualifies as General Wellness Devices?

A product is considered a general wellness device if it:

• Encourages fitness, relaxation, or better sleep
• Poses minimal risk (non-invasive and no high-risk technology)

For example, a tracker promoting heart health through activity support is a general wellness device. But a tracker claiming to detect heart disease becomes a regulated medical device requiring approval.

Why the Distinction Matters

Understanding general wellness devices helps consumers make informed choices and supports developers in staying compliant. Clear classification of general wellness devices ensures safe innovation while remaining within regulatory boundaries.