K203181 is an FDA 510(k) clearance for the Nerivio, FGD000075-4.7. 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 Cleared decision on January 22, 2021, 88 days after receiving the submission on October 26, 2020.
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 | K203181 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 26, 2020 |
| Decision Date | January 22, 2021 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |