DEN180041 is an FDA 510(k) submission for the Monarch eTNS System. This device is classified as a Transcutaneous Nerve Stimulator For Adhd (Class II - Special Controls, product code QGL).
Submitted by Neurosigma, Inc. (Los Angeles, US). The FDA issued a Not Cleared (DENG) decision on April 19, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5898. A Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder (adhd) Is A Prescription Device That Stimulates Transcutaneously Or Percutaneously Through Electrodes Placed On The Forehead..
| 510(k) Number | DEN180041 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 30, 2018 |
| Decision Date | April 19, 2019 |
| Days to Decision | 263 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QGL - Transcutaneous Nerve Stimulator For Adhd |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5898 |
| Definition | A Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder (adhd) Is A Prescription Device That Stimulates Transcutaneously Or Percutaneously Through Electrodes Placed On The Forehead. |