Product code
PZR: Percutaneous nerve stimulator for opioid withdrawal
FDA product code · Class II · Neurology
Key facts
| Product code | PZR |
|---|---|
| Device | Percutaneous nerve stimulator for opioid withdrawal |
| Device class | Class II |
| Regulation number | 882.5896 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database