QAR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Thermal Vestibular Stimulator For Headache
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5893
- Medical specialty
- Neurology
- FDA definition
- The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ThermoNeuroModulation Device, TNM Device (DEN170023) | Scion Neurostim, LLC | 2018-03-26 |
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