Is S-Patch CardioAI FDA approved or cleared?
Yes. S-Patch CardioAI by Wellysis Corp. is named in the FDA register with a 510(k) clearance, first authorised in 2023, latest decision in 2026.
In the EU: CE class IIa, found in EUDAMED. No notified body certificate is visible in EUDAMED yet; ask the maker for it (devices still under the older MDD rules often have none listed).
At a glance
| Product | S-Patch CardioAI |
|---|---|
| Maker | Wellysis Corp. |
| Care area | Heart & circulation |
| What it does | Wearable ECG patch with AI analysis for ambulatory heart rhythm monitoring |
| FDA | 510(k), latest decision 2026 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | Class IIa |
| EU certificate | Not visible in EUDAMED yet (checked 18 October 2026) |
| Website | wellysis.com |
| Status | FDA verified |
| Last checked | 7 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
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