Is PainChek FDA approved or cleared?
Yes. PainChek by PainChek Ltd. is named in the FDA register with a De Novo authorisation, latest decision in 2025.
In the EU: CE class I (self-declared by the maker).
At a glance
| Product | PainChek |
|---|---|
| Maker | PainChek Ltd. |
| Care area | Pain & neuromodulation |
| What it does | Smartphone app that uses facial analysis to assess pain in people who cannot speak |
| FDA | De Novo, latest decision 2025 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | Class I (self-declared) |
| Website | painchek.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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