K223169 is an FDA 510(k) clearance for the Nerivio. 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 February 6, 2023, 118 days after receiving the submission on October 11, 2022.
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 | K223169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2022 |
| Decision Date | February 06, 2023 |
| Days to Decision | 118 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. |