Is a Health & Fitness app a medical device?
Health & Fitness is a shelf. The new label is the actual answer.
Apple started showing whether an app is a regulated medical device on App Store product pages in the United States, the United Kingdom and the European Economic Area on 26 March 2026. A lot of people saw that label next to Health & Fitness and assumed the category was the answer. It is not.
This post is how to read the label. It is also a straight answer to the question people then ask us: is ftns.ai a medical app? No. ftns.ai is a game in the Health & Fitness category, not a medical product. We do not diagnose, treat or assess anything.
This sits next to the 2026 care-loop map. Those games live on that shelf. This is what that shelf is not.
Is a fitness app a medical device?
No. Most fitness apps are habit and tracking games, not medical devices, and sitting in the Health & Fitness category does not change that.
Apple’s own rule is a declaration, not a category inference. If you distribute in the EEA, UK or US and your app’s primary or secondary category is Health & Fitness or Medical — or you marked frequent Medical or Treatment Information in the age-rating questionnaire — you have to say whether the app is a regulated medical device. If it is not, you select No ([Apple Developer News, 26 March 2026](https://developer.apple.com/news/?id=nyqbfz1y); [App Store Connect Help](https://developer.apple.com/help/app-store-connect/manage-app-information/declare-regulated-medical-device-status), fetched 20 August 2026).
That is the mechanism. A workout logger, a streak game and a virtual-pet habit app can all sit on the Health & Fitness shelf and still be a No. The shelf tells you where the app is filed. The label tells you whether the developer says it is a device.
What does “regulated medical device” on an App Store page mean?
A regulated medical device, on an App Store product page, is an app the developer has declared is used — on its own or as part of a system — for medical purposes such as diagnosis, prevention, monitoring or treatment of diseases and physiological conditions, and that may require registration or authorisation from a body such as the US Food and Drug Administration ([Apple Developer News, 26 March 2026](https://developer.apple.com/news/?id=nyqbfz1y)).
Apple’s form has three statuses ([App Store Connect Help](https://developer.apple.com/help/app-store-connect/manage-app-information/declare-regulated-medical-device-status), fetched 20 August 2026):
| Status | What it means |
|---|---|
| Yes | The developer declared the app is a regulated medical device in that country or region and entered the required information. |
| No | The developer indicated the app is not a regulated medical device in that country or region. |
| Missing Info | The developer said Yes but has not finished the required fields. |
A Yes is not a vibe. It comes with contact details and safety information, and in some cases an EU Manufacturer SRN or FDA Owner/Operator Number, an instructions-for-use URL, and a use statement. That packet is what then shows on the product page.
Apple’s own test for “how to know” is specific: FDA clearance or approval, a listing on the US FDA medical device database, a CE mark under the EU MDR or MDD, a UKCA mark, or self-certification under those EU or UK rules. If none of that applies, the honest selection is No.
New apps that meet the criteria have had to provide a status since 26 March 2026 to distribute in those regions. Existing apps must provide one by early 2027. Miss that deadline and you can no longer submit updates ([Apple Developer News, 26 March 2026](https://developer.apple.com/news/?id=nyqbfz1y)).
We are not going to invent a screenshot of any live product page, including ours. Read the label on the page in front of you.
Does Health & Fitness category mean FDA-cleared?
No. Health & Fitness is an App Store category — a shelf — and FDA clearance or approval is a separate regulatory fact that a Yes declaration is meant to surface.
Apple requires the declaration because an app is in Health & Fitness or Medical, or because it marked frequent medical or treatment references in the age-rating questionnaire. The requirement to answer is not the same as the answer being Yes ([App Store Connect Help](https://developer.apple.com/help/app-store-connect/manage-app-information/declare-regulated-medical-device-status), fetched 20 August 2026).
Finch sits in Health & Fitness, age 9+, seller Finch Care Public Benefit Corporation, as of the US listing fetched on 20 August 2026 ([Finch on the App Store](https://apps.apple.com/us/app/finch-self-care-pet/id1528595748)). Twinsi sits in Health & Fitness, age 18+, seller Nutmeg.ai, Inc., as of the US listing fetched the same day ([Twinsi on the App Store](https://apps.apple.com/us/app/twinsi/id6753560471)). Category membership is not a clearance. It is where the store put the icon.
If you need an FDA-cleared or CE-marked tool, look for the Yes and the regulatory packet, then confirm with a clinician. Do not infer clearance from the Health & Fitness badge.
Does connecting Apple Health make an app a medical product?
No. Connecting Apple Health does not make an app a medical product.
Apple Health is a store of data the iPhone already has — steps, workouts, sleep and the rest. An app can read those numbers to drive a game character, fill a log, or draw a chart. That is not the same as diagnosing, treating or assessing a condition.
The App Store label asks what the app is for, not whether it can see a step count. Two apps can both read Apple Health and still sit on opposite sides of the declaration: one is a habit game, one is a cleared clinical signal. The data pipe is shared. The job is not.
ftns.ai uses real behaviour — workouts, sleep, steps, food, water, weight, mood — to drive a full-colour, 3D-accurate twin and a Life Score. That is game input. It is not a clinical reading. We do not diagnose, treat or assess anything. Whether any given app requires an Apple Health connection is a product choice; the medical-device question is about the claim, not the cable.
Is ftns.ai a medical app?
No. ftns.ai is a game in the Health & Fitness category, not a medical product. We do not diagnose, treat or assess anything.
You keep a full-colour, 3D-accurate digital twin of yourself. The twin changes with the week you actually lived. Everything you log rolls into one Life Score. Future Self can project that twin across six horizons and three timelines, free and unlimited. None of that is a diagnosis. The twin is not a body scan. A Life Score is not a medical score.
The game is private-first: no feed, no friends list, no leaderboards, ever. Sharing is one score card or Future Self image you export yourself. The app never posts. Free to play; Premium is $4.99 a month and buys cosmetics, gems and boosts only. Core function is not paywalled.
When should you pick a medical app instead?
You should pick a declared medical app — and a clinician — when you need diagnosis, treatment, or a cleared clinical signal.
An ECG read, a clinical continuous-glucose alert, a prescribed therapy, a tool that claims to detect or manage a disease: those jobs belong to a Yes, with the regulatory packet on the product page, and to a person who is allowed to interpret it. A habit game is the wrong instrument, including ours, including Finch, including any other care-loop app on that map.
If what you want is a character that reacts when you skip a week, stay on the game shelf. If what you want is a medical conclusion, leave it.
Game, pet, or device?
A game, a self-care pet, and a regulated medical device are three different jobs. Finch is a better fit than we are if the job is a gentle mood pet. A declared medical device is a better fit than either of us if the job is clinical.
| Health & Fitness game (ftns.ai) | Self-care pet (Finch) | Medical / regulated device | |
|---|---|---|---|
| Job | Keep a habit loop going through a character that is you | Mood, reflection, small self-care tasks through a bird | Diagnose, prevent, monitor or treat a condition |
| App Store category | Health & Fitness | Health & Fitness ([US listing, 20 August 2026](https://apps.apple.com/us/app/finch-self-care-pet/id1528595748)) | Medical, or Health & Fitness with a Yes declaration |
| Diagnoses, treats or assesses? | No | No | Yes — that is the job |
| Honest selection on Apple’s form | Select No | Select No | Select Yes, plus the regulatory packet |
| Example | ftns.ai | Finch | An FDA-cleared ECG app or a clinical CGM alert app |
Selections are what the form asks for, not a scraped screenshot of any live product page.
Next: the care-loop map, how the Life Score works, and what we do with a twin that looks like you.
Frequently asked questions
Is a fitness app a medical device?
No. Most fitness apps are habit and tracking games, not medical devices. An app in the Health & Fitness category still has to declare Yes or No on Apple’s regulated-medical-device form for the US, UK and EEA. Category is not clearance. Source: Apple Developer News, 26 March 2026.
What does “regulated medical device” mean on the App Store?
It means the developer declared the app is used for medical purposes such as diagnosis, prevention, monitoring or treatment, and may need authorisation from a body such as the FDA. The product-page statuses are Yes, No, and Missing Info. Source: App Store Connect Help, fetched 20 August 2026.
Does Health & Fitness mean an app is FDA approved?
No. Health & Fitness is an App Store category. FDA clearance or approval is a separate fact. Apple’s Yes declaration is how that fact is supposed to appear on the US, UK and EEA product pages, alongside CE and UKCA marks in those regions.
Does Apple Health make an app a medical device?
No. Connecting Apple Health does not make an app a medical product. Apple Health stores data the iPhone already has. The App Store label is about what the app claims to do with data, not whether it can read steps, workouts or sleep.
Is ftns.ai a medical app?
No. ftns.ai is a game in the Health & Fitness category, not a medical product. We do not diagnose, treat or assess anything. The full-colour 3D-accurate twin is not a body scan or a clinical reading. A Life Score is not a medical score.
When should I use a medical app instead of a fitness game?
Use a declared medical app, and a clinician, when you need diagnosis, treatment or a cleared clinical signal — for example an ECG read or a clinical CGM alert. A habit game, including ftns.ai, is the wrong tool for that job.