What Counts as a General Wellness Device—And What Doesn’t
- Bustos Law Group
- Sep 8
- 2 min read
Updated: Nov 21
Not every product that promotes health is exempt from FDA regulation.
The agency’s General Wellness Guidance outlines what qualifies as a low-risk wellness device—and what crosses the line into regulated medical device territory.
In this blog, we break down the FDA’s criteria, share examples of compliant products, and highlight recent enforcement actions against brands that misclassified their devices.
What Is a General Wellness Device?
According to the FDA, a general wellness product is one that:
Is intended only for general wellness use, such as promoting relaxation, sleep, fitness, or mental acuity.
Poses a low risk to users [1].
These products are not actively regulated as medical devices if they avoid disease-related claims and don’t perform diagnostic or therapeutic functions.
Examples of Acceptable General Wellness Devices
The FDA lists several examples of products that typically fall within the general wellness category [1] [2]:
Fitness trackers that count steps or calories.
Sleep monitors that track patterns without diagnosing sleep disorders.
Meditation apps that promote stress reduction.
Smart scales that measure weight and body composition without medical interpretation.
These products are considered low-risk and are marketed for general lifestyle improvement—not for diagnosing, treating, or preventing disease.
Where Brands Get Into Trouble
The line between general wellness and medical device is thin—and several companies have crossed it.
Case Study: WHOOP Inc.
In July 2025, the FDA issued a warning letter to WHOOP Inc. for its wearable device’s Blood Pressure Insights feature [2]. Although WHOOP marketed the product as a wellness tool, the FDA determined that:
Estimating systolic and diastolic blood pressure is inherently diagnostic.
Claims like “medical-grade health & performance insights” implied clinical utility.
The product was adulterated and misbranded under the FD&C Act because it lacked FDA clearance.
This case underscores that functionality—not just marketing language—determines regulatory status.
How to Stay Compliant
If you’re developing or marketing a wellness product, follow these best practices:
Avoid disease-related claims
Don’t mention conditions like insomnia, hypertension, depression, or diabetes.
Focus on general health benefits
Use language like “supports relaxation,” “encourages healthy sleep,” or “promotes physical activity.”
Limit functionality
Avoid features that measure or interpret clinical data (e.g., blood pressure, glucose levels).
Consult FDA guidance early
Review the General Wellness Guidance and seek legal review before launch.
Conclusion
General wellness devices offer exciting opportunities—but they must be carefully positioned to avoid FDA scrutiny.
If your product falls into the diagnostic or therapeutic category, it may require premarket clearance and full compliance with medical device regulations.
If you’re unsure whether your product qualifies as a general wellness device, contact Bustos Law Group. This is where we step in.
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