K211380 is an FDA 510(k) clearance for the Elexir. This device is classified as a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II - Special Controls, product code PCC).
Submitted by Nu Eyne Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 30, 2021, 87 days after receiving the submission on May 4, 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 | K211380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2021 |
| Decision Date | July 30, 2021 |
| Days to Decision | 87 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. |