De Novo
DEN110009: RESTLESS LEG DEVICE
FDA De Novo · mary m. sorg (an individual) dba pj sleeper's · decided Dec 18, 2013
Key facts
| De Novo number | DEN110009 |
|---|---|
| Device name | RESTLESS LEG DEVICE |
| Applicant | mary m. sorg (an individual) dba pj sleeper's |
| Product code | OTX |
| Date received | Jan 27, 2011 |
| Decision date | Dec 18, 2013 |
| Decision | granted (DENG) |
| FDA classification | Class I |
| Review panel | Neurology |
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: