De Novo
DEN200046: Neurolutions Upper Extremity Rehabilitation System
FDA De Novo · neurolutions, inc. · decided Apr 23, 2021
Key facts
| De Novo number | DEN200046 |
|---|---|
| Device name | Neurolutions Upper Extremity Rehabilitation System |
| Applicant | neurolutions, inc. |
| Product code | QOL |
| Date received | Jul 23, 2020 |
| Decision date | Apr 23, 2021 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Physical Medicine |
| FEI number | 3030779215 |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: