510(k) DEN170023
DEN170023 is an FDA 510(k) premarket notification submitted by Scion Neurostim, LLC for the device "ThermoNeuroModulation Device, TNM Device". The FDA issued a decision of De Novo Granted on March 26, 2018. The device falls under product code QAR (Thermal Vestibular Stimulator For Headache), a Class II device regulated under 21 CFR 882.5893.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 26, 2018
- Date Received
- April 17, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thermal Vestibular Stimulator For Headache
- Device Class
- Class II
- Regulation Number
- 882.5893
- Review Panel
- NE
- Submission Type
The device is intended to stimulate the vestibular system using thermal waveforms in the ear canals for treatment of migraine headache.