QAR — Thermal Vestibular Stimulator For Headache Class II
FDA product code QAR covers "Thermal Vestibular Stimulator For Headache", a Class II medical device regulated under 21 CFR 882.5893. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QAR
- Device Class
- Class II
- Regulation Number
- 882.5893
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170023 | scion neurostim | ThermoNeuroModulation Device, TNM Device | March 26, 2018 |