Is IpsiHand FDA approved or cleared?
Yes. IpsiHand by Neurolutions, Inc. is named in the FDA register with a De Novo authorisation, latest decision in 2021.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | IpsiHand |
|---|---|
| Maker | Neurolutions, Inc. |
| Care area | Muscles, bones & rehab |
| What it does | Brain-computer interface hand orthosis for stroke rehabilitation at home |
| FDA | De Novo, latest decision 2021 |
| Verification level | Exact product named in the FDA record (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | neurolutions.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