Product code
PKR: Non-invasive vagus nerve stimulator - headache
FDA product code · Class II · Neurology
Key facts
| Product code | PKR |
|---|---|
| Device | Non-invasive vagus nerve stimulator - headache |
| Device class | Class II |
| Regulation number | 882.5892 |
| Review panel | Neurology |
| Medical specialty | Neurology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- None 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