Is PainX® TENS certified as a medical device?
We could not confirm the certification that PainX® TENS claims in the FDA register, EUDAMED or the German DiGA directory. It is on our public watchlist until the maker provides a reference number we can verify.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | PainX® TENS |
|---|---|
| Maker | Soteris Medical |
| Care area | Pain & neuromodulation |
| What it does | Transcutaneous electrical nerve stimulation device for pain management |
| FDA | No FDA authorisation found |
| EU (CE) | No CE listing found |
| Website | soterixmedical.com/PainXTENS/get |
| Status | Watchlist |
| Last checked | 6 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