DEN180059 is an FDA 510(k) submission for the Nerivio Migra. This device is classified as a Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine (Class II - Special Controls, product code QGT).
Submitted by Theranica Bioelectronics , Ltd. (Netanya, IL). The FDA issued a Not Cleared (DENG) decision on May 20, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5899. A Trunk And Limb Electrical Stimulator To Treat Headache Is A Device Intended To Treat Headache Through The Application Of Electrical Stimulation Anywhere On The Body Of The Patient Apart From The Patient's Head Or Neck Through Electrodes Placed On The Skin. The Stimulation May Be Provided Transcutaneously Or Percutaneously..
| 510(k) Number | DEN180059 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 06, 2018 |
| Decision Date | May 20, 2019 |
| Days to Decision | 195 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QGT - Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5899 |
| Definition | A Trunk And Limb Electrical Stimulator To Treat Headache Is A Device Intended To Treat Headache Through The Application Of Electrical Stimulation Anywhere On The Body Of The Patient Apart From The Patient's Head Or Neck Through Electrodes Placed On The Skin. The Stimulation May Be Provided Transcutaneously Or Percutaneously. |