K203419 is an FDA 510(k) clearance for the Relivion. This device is classified as a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II - Special Controls, product code PCC).
Submitted by Neurolief , Ltd. (Netanya, IL). The FDA issued a Cleared decision on February 16, 2021, 89 days after receiving the submission on November 19, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5891. Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin..
| 510(k) Number | K203419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2020 |
| Decision Date | February 16, 2021 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PCC - Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5891 |
| Definition | Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin. |