FDA cleared or wellness: what the label on your wearable means
The same watch can have one feature the FDA reviewed and ten it never looked at. Here is how to tell them apart, what the words on the box mean, and how to check a claim yourself.
From Dr. Kenny Civello, cardiologist and electrophysiologist
A medical feature on a wearable, like an ECG app, has to show the FDA that it does what the company claims. A wellness feature, like a sleep score or a stress number, does not. Both can live on the same device and look just as official on your screen.
Medical features
Claim to detect, screen for, or help diagnose a condition, like AFib or sleep apnea. The FDA reviewed the company's evidence before it could sell them.
Wellness features
Claim to support general health, like sleep, fitness, or stress. The FDA does not review them. The FDA says that being wellness does not show a product is safe or that it works.
Why it matters to you
When we make a decision about your heart, I rely on a cleared feature or a medical test. Wellness numbers can still show trends worth talking about.
Why a company might choose wellness
FDA review takes time and money. It also locks the company into the claims the FDA accepted. Selling a feature as wellness is faster and freer. That is not wrong, but it means nobody outside the company checked the numbers.
What the words on the box mean
Marketing often blurs these. Only the first three mean the FDA reviewed something.
| The claim | What it means | FDA reviewed it? |
|---|---|---|
| FDA cleared | The FDA found the feature works like one already on the market. This is how most wearable features reach you. The record number starts with K. | Yes |
| FDA granted | The first feature of its kind, reviewed through the De Novo path. The record number starts with DEN. Companies often call this cleared. | Yes |
| FDA approved | The strictest review, for the highest risk devices like implanted heart devices. Almost no wearable feature goes through it. People often say approved when they mean cleared. | Yes |
| FDA registered or FDA certified | The company listed itself with the FDA. The FDA does not issue registration certificates, and registration does not mean a product was reviewed. | No |
| Clinically validated, medical grade, or clinical grade | No FDA definition. The company's own claim. Under the 2026 wellness rules, a wellness product is not supposed to claim clinical or medical grade accuracy. | No |
| FDA compliant | No FDA definition. On its own, it tells you nothing. | No |
Decode a claim
Pick the phrase you saw on the box, the app, or an ad.
What changed in 2026
In January 2026 the FDA updated its rules for wellness products. You will see more medical looking numbers that the FDA never reviewed.
More numbers on wellness devices
A wellness wearable may now show estimates of blood pressure, blood oxygen, and heart rate variability, including trends and baselines, as long as it is not used to diagnose or treat anything.
Limits on what they can say
A wellness product should not name a disease, call your number abnormal, set off alerts that tell you to get care, or claim clinical accuracy. It may say that talking with a health professional could help.
What it means for you
A blood pressure number on a wellness band is an estimate the FDA did not check. For decisions about your blood pressure, use a validated upper arm cuff. See Best home blood pressure monitor.
An example: WHOOP and blood pressure
In July 2025, the FDA sent WHOOP a warning letter saying its Blood Pressure Insights feature was being sold as a medical device without FDA review. WHOOP disagreed and kept the feature. In June 2026, after WHOOP changed the feature and its labels, and after the new wellness rules, the FDA closed the letter. The feature is still not FDA cleared. The ECG on the same WHOOP band is. One device, two very different features.
Watches and rings that claim to measure blood sugar
In 2024 the FDA warned people not to use smartwatches or rings that claim to measure blood sugar without piercing the skin. None has been authorized, and wrong readings can lead to dangerous dosing mistakes. Glucose sensors that stick to your skin with a tiny filament, like Dexcom Stelo and Abbott Lingo, are a different thing. They are FDA cleared and sold over the counter.
Check a claim yourself
It takes about five minutes.
Name the feature
Not the watch. Write down the exact feature, like ECG app or sleep apnea notifications.
Look up my list
The FDA cleared wearables list covers heart, blood pressure, sleep apnea, and blood oxygen features, with links to each FDA record.
Search the FDA
Search the company name in the FDA 510(k) database and the De Novo database. Find the record that names your feature.
Read who it is for
The record says who the feature is meant for, like adults 22 and older, or people without a diagnosis. A feature used outside that group has not been shown to work there.
Common questions
Is FDA cleared the same as FDA approved?
No, but for wearables, cleared is the normal and correct standard. Approved is a stricter path used for the highest risk devices. A cleared wearable feature has been reviewed. It is not a lesser product for being cleared instead of approved.
Are wellness features useless?
No. Sleep, activity, and resting heart rate trends can be helpful, especially when you compare yourself with yourself over time. Just do not treat a wellness number as a diagnosis.
Does FDA clearance mean it will be right for me?
It means the company showed it works in the people it tested, used the way the label says. Cleared features still miss things and still give false alarms. A doctor confirms the diagnosis.
Can you use my wellness data at my visit?
Yes, as background. Bring trends and screenshots. For decisions, we will usually confirm with a cleared feature like an ECG recording, or with a medical test.
More on wearables
My watch says I have AFibMy watch ECG says inconclusiveIrregular rhythm notifications, explainedMy watch says my heart rate is high or lowMy watch says I may have sleep apneaWhich wearable features are FDA clearedHow I choose the wearables I recommendFind the right wearableBest smartwatch for catching AFibBest smart ring for sleepBest home blood pressure monitorBest personal ECG without a smartwatchBest wearable for an older parentBest wearable for athletesBest wearable without a screenThis page is general education for my patients. It does not replace advice from your own doctor. Device names are trademarks of their makers. This page is not affiliated with any of them.
Sources: FDA. General Wellness: Policy for Low Risk Devices. Guidance, January 2026. FDA. Is it really FDA approved? Consumer update. FDA warning letter to WHOOP, Inc., July 14, 2025, and closeout letter, June 17, 2026. FDA. Do not use smartwatches or smart rings to measure blood glucose levels. Safety communication, February 2024.