510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212071Substantially Equivalent

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

Cefaly Technology, Seraing, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212071 is the FDA 510(k) clearance record for Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx, a class II device, cleared for Cefaly Technology on under FDA product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine). FDA's definition for product code PCC reads: "Used to apply an electrical current to a patient's cranium through electrodes placed on the skin". FDA records list 6 510(k) clearances for Cefaly Technology, from to . As of , FDA records show no recalls naming K212071.

Clearance record

Decision date
Received
(529 days to decision)
Product code
PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Regulation
21 CFR 882.5891
Device class
Class II
Review panel
Neurology
Applicant
Cefaly Technology Rue Louis Plescia, 34, Seraing, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PCC

Trailing 12 months
1 clearance under product code PCC in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PCC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260