Product code QAR
- Device name
- Thermal Vestibular Stimulator For Headache
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5893
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN170023 | ThermoNeuroModulation Device, TNM Device | Scion Neurostim, LLC | 2018-03-26 |