The short answer
Many fitness trackers, smart rings, massagers, posture correctors, sleep and relaxation gadgets are “general wellness” products that FDA does not actively regulate as medical devices — if they are low risk and their claims stay away from disease. FDA updated its General Wellness: Policy for Low Risk Devices guidance on January 6, 2026, adding criteria for wearables that use non-invasive sensors to estimate values such as blood pressure, oxygen saturation, blood glucose or heart rate variability.
The two tests
| Test | To qualify |
|---|---|
| 1. Intended use | Either (a) maintaining or encouraging a general state of health or a healthy activity, unrelated to any disease; or (b) linking a healthy lifestyle to reducing the risk or impact of certain chronic diseases, where that link is well accepted |
| 2. Low risk | Not invasive or implanted, and does not involve a technology that could pose a safety risk without specific regulatory controls (for example lasers or high-power energy) |
Claims: wellness or medical device?
| Claim | Usually |
|---|---|
| “Tracks steps, sleep and activity to help you stay fit” | General wellness |
| “Helps you relax and manage everyday stress” | General wellness |
| “Massager for tired muscles after exercise” | General wellness |
| “Regular physical activity, tracked by this app, may help reduce the risk of high blood pressure” | General wellness (category b) |
| “Detects atrial fibrillation”, “diagnoses sleep apnea” | Medical device |
| “Treats back pain”, “relieves arthritis”, “reduces swelling” | Medical device |
| “Alerts you to see a doctor when your blood pressure is high” | Medical device — prompts clinical action |
The 2026 wearables criteria
A non-invasive wearable that estimates or outputs physiologic values can still be general wellness only if it:
- is not intended to diagnose, prevent or treat a disease or condition;
- is not intended as a substitute for an FDA-cleared, authorized or approved device;
- does not include claims, functions or outputs that prompt or guide specific clinical action; and
- does not show values that mimic clinical values unless they are validated.
Example: a smart ring from Finland and a massage gun from China
A Finnish smart ring maker tracks sleep, pulse rate and an estimated blood pressure trend. Its U.S. app shows validated values, presents them for general fitness, and does not suggest diagnoses or tell users to seek treatment — so it stays within the general wellness policy. A Chinese massage gun brand removes “relieves arthritis and sciatica” from its listing and keeps “helps tired muscles recover after workouts”.
Medical device registration and U.S. Agent $550 per year (FDA user fee separate). Device listing $50 per device. Medical device label review $550.
Frequently asked questions
Are fitness trackers regulated by FDA?
Generally not, if they are low risk and only make general wellness claims. Claims to diagnose or treat disease make them medical devices.
What changed in FDA’s 2026 general wellness guidance?
FDA added criteria for non-invasive wearables that estimate values such as blood pressure, oxygen saturation, blood glucose and heart rate variability.
Is a massager a medical device?
A massager for relaxation or tired muscles is usually general wellness. One that claims to treat pain conditions or disease is a medical device.
Do general wellness products need FDA registration?
Not if they meet the policy. FDA does not intend to examine low-risk general wellness products for compliance with device requirements.
Sources
- Congressional Research Service — FDA oversight of general wellness products (February 17, 2026)
- Troutman Pepper Locke — FDA’s 2026 guidance on general wellness devices
Policy checked on November 12, 2026. This article is general information, not legal advice.