De Novo
DEN170023: ThermoNeuroModulation Device, TNM Device
FDA De Novo · scion neurostim, llc · decided Mar 26, 2018
Key facts
| De Novo number | DEN170023 |
|---|---|
| Device name | ThermoNeuroModulation Device, TNM Device |
| Applicant | scion neurostim, llc |
| Product code | QAR |
| Date received | Apr 17, 2017 |
| Decision date | Mar 26, 2018 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Neurology |
| FEI number | 3010120223 |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None 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: