Cleared Traditional

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx

K212071 · Cefaly Technology · Neurology
Dec 2022
Decision
529d
Days
Class 2
Risk

About This 510(k) Submission

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, 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 review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number K212071 FDA.gov
FDA Decision Cleared 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

Device Classification

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.