DeviceClearance

Product code PCC— Neurology

Cefaly Dual

Classification name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device class
Class 2
Regulation
21 CFR 882.5891
Advisory panel
Neurology
Total cleared
18
First cleared
Most recent

FDA classification definition

“Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.”

— U.S. Food and Drug Administration, device classification record for product code PCC under 21 CFR 882.5891, via openFDA

Market context for product code PCC

FDA has cleared 18 devices under product code PCC between 2014 and 2026, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PCC

Adverse events under product code PCC

product code PCC
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PCC

Data sourced from openFDA. This site is unofficial and independent of the FDA.