K212106 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 August 2, 2021, 27 days after receiving the submission on July 6, 2021.
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 | K212106 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2021 |
| Decision Date | August 02, 2021 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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. |