Is MyndStep™ Stimulator certified as a medical device?
We could not confirm the certification that MyndStep™ Stimulator 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 | MyndStep™ Stimulator |
|---|---|
| Maker | MyndTec, Inc. |
| Care area | Brain & nerves |
| What it does | Functional electrical stimulation system for stroke and spinal cord injury rehabilitation |
| FDA | 510(k), latest decision 2024 (product family) |
| EU (CE) | No CE listing found |
| Website | myndtec.com |
| 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
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