Product code
QAR: Thermal vestibular stimulator for headache
FDA product code · Class II · Neurology
Key facts
| Product code | QAR |
|---|---|
| Device | Thermal vestibular stimulator for headache |
| Device class | Class II |
| Regulation number | 882.5893 |
| 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 is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache. |
At a glance
- None 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None 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