Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

FDA product code PCC · Class II (moderate risk) · 21 CFR 882.5891 · Neurology

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

17510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K254216Enso for MigrainePCC · Traditional Hinge Health, Inc.04/16/2026SE
K242719Elexir 2.0 (ALLIVE3)PCC · Traditional Nu Eyne Co., Ltd.11/06/2024SE
K234029CEFALY Connected - OTC, CEFALY Connected - RxPCC · Traditional Cefaly Technology07/18/2024SE
K232749DoopangPCC · Traditional Ybrain, Inc.06/11/2024SE
K233751Milieve (YPS-301BD)PCC · Traditional Soterix Medical, Inc.06/03/2024SE
K230782TENS device-HeadaTerm 2 (Model: YF-HT2)PCC · Traditional Wat Medical Technology, Inc.02/26/2024SE
K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…PCC · Traditional Cefaly Technology12/13/2022SE
K212106RelivionPCC · Special Neurolief , Ltd.08/02/2021SE
K211380ElexirPCC · Traditional Nu Eyne Co., Ltd.07/30/2021SE
K210364Migraine Tens Digital Pain RelieverPCC · Traditional Shenzhen Dongdixin Technology Co., Ltd.06/17/2021SE
K203419RelivionPCC · Traditional Neurolief , Ltd.02/16/2021SE
K201895Cefaly DualPCC · Traditional Cefaly Technology09/29/2020SE
K192773AllivePCC · Traditional Nu Eyne Co., Ltd.12/06/2019SE
K172450TENS device-HeadaTerm, eEspressPCC · Traditional Wat Medical Technology (Ningbo) Co., Ltd.09/13/2018SE
K173006Cefaly DualPCC · Traditional Cefaly Technology11/28/2017SE
K171446Cefaly AcutePCC · Traditional Cefaly Technology09/15/2017SE
K160237CefalyPCC · Special Cefaly Technology03/04/2016SE