K160237 is an FDA 510(k) clearance for the Cefaly. This device is classified as a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II - Special Controls, product code PCC).
Submitted by Cefaly Technology (Herstal, BE). The FDA issued a Cleared decision on March 4, 2016, 32 days after receiving the submission on February 1, 2016.
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 | K160237 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2016 |
| Decision Date | March 04, 2016 |
| Days to Decision | 32 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. |