K212071 is an FDA 510(k) clearance for the Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx. This device is classified as a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II - Special Controls, product code PCC).
Submitted by Cefaly Technology (Seraing, BE). The FDA issued a Cleared decision on December 13, 2022, 529 days after receiving the submission on July 2, 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 | K212071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2021 |
| Decision Date | December 13, 2022 |
| Days to Decision | 529 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. |