De Novo
DEN100023: AHIP INTERNAL TRIGGER POINT WAND MODEL: 1
FDA De Novo · national center for pelvic pain research devices, · decided Nov 20, 2012
Key facts
| De Novo number | DEN100023 |
|---|---|
| Device name | AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 |
| Applicant | national center for pelvic pain research devices, |
| Product code | OSD |
| Date received | Aug 20, 2010 |
| Decision date | Nov 20, 2012 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Physical Medicine |
At a glance
- None Later 510(k)s citing this De Novo
- 1–9 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: