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PCC — Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Class II

FDA Device Classification

Classification Details

Product Code
PCC
Device Class
Class II
Regulation Number
882.5891
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242719nu eyne coELEXIR 2.0 (ALLIVE3)November 6, 2024
K234029cefaly technologyCEFALY Connected - OTC, CEFALY Connected - RxJuly 18, 2024
K232749ybrainDOOPANGJune 11, 2024
K233751soterix medicalMilieve (YPS-301BD)June 3, 2024
K230782wat medical technologyTENS device-HeadaTerm 2 (Model: YF-HT2)February 26, 2024
K212071cefaly technologyCefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, CefalDecember 13, 2022
K212106neuroliefRelivionAugust 2, 2021
K211380nu eyne coElexirJuly 30, 2021
K210364shenzhen dongdixin technology coMigraine Tens Digital Pain RelieverJune 17, 2021
K203419neuroliefRelivionFebruary 16, 2021
K201895cefaly technologyCefaly DualSeptember 29, 2020
K192773nu eyne coALLIVEDecember 6, 2019
K172450wat medical technology (ningbo) coTENS device-HeadaTerm, eEspressSeptember 13, 2018
K173006cefaly technologyCefaly DualNovember 28, 2017
K171446cefaly technologyCefaly AcuteSeptember 15, 2017
K160237cefaly technologyCefalyMarch 4, 2016
DEN120019stx-med sprlCEFALYMarch 11, 2014