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PCC

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

Product code
PCC
Device name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device class
Class 2
21 CFR
21 CFR 882.5891
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
6
Summaries archived here
6 (direct download)
510(k) clearances (all years, FDA)
18 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2026-04-16.

NumberDecision dateApplicantDevice nameSummary
K2542162026-04-16Hinge Health, Inc.Enso for MigrainePDF
K2427192024-11-06Nu Eyne Co., Ltd.ELEXIR 2.0 (ALLIVE3)PDF
K2340292024-07-18Cefaly TechnologyCEFALY Connected - OTC, CEFALY Connected - RxPDF
K2327492024-06-11Ybrain, Inc.DOOPANGPDF
K2337512024-06-03Soterix Medical, Inc.Milieve (YPS-301BD)PDF
K2307822024-02-26Wat Medical Technology, Inc.TENS device-HeadaTerm 2 (Model: YF-HT2)PDF

6 summaries are archived here for direct download.

Official FDA classification page: PCC
Classification and pathway per current FDA publications. Data from openFDA (CC0).