Atlas FDA

PCC

18 FDA 510(k) clearances · Product code

122 daysmedian time to decision
453 days90th percentile
18clearances measured

FDA profile

Official device name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5891
Medical specialty
Neurology
FDA definition
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
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RecordFirmDate
Enso for Migraine (K254216)Hinge Health, Inc.2026-04-16
ELEXIR 2.0 (ALLIVE3) (K242719)Nu Eyne Co., Ltd.2024-11-06
CEFALY Connected - OTC, CEFALY Connected - Rx (K234029)Cefaly Technology2024-07-18
DOOPANG (K232749)Ybrain, Inc.2024-06-11
Milieve (YPS-301BD) (K233751)Soterix Medical, Inc.2024-06-03
TENS device-HeadaTerm 2 (Model: YF-HT2) (K230782)Wat Medical Technology, Inc.2024-02-26
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (K212071)Cefaly Technology2022-12-13
Relivion (K212106)Neurolief , Ltd.2021-08-02
Elexir (K211380)Nu Eyne Co., Ltd.2021-07-30
Migraine Tens Digital Pain Reliever (K210364)Shenzhen Dongdixin Technology Co., Ltd.2021-06-17
Relivion (K203419)Neurolief , Ltd.2021-02-16
Cefaly Dual (K201895)Cefaly Technology2020-09-29
ALLIVE (K192773)Nu Eyne Co., Ltd.2019-12-06
TENS device-HeadaTerm, eEspress (K172450)Wat Medical Technology (Ningbo) Co., Ltd.2018-09-13
Cefaly Dual (K173006)Cefaly Technology2017-11-28
Cefaly Acute (K171446)Cefaly Technology2017-09-15
Cefaly (K160237)Cefaly Technology2016-03-04
CEFALY (DEN120019)Stx-Med Sprl2014-03-11

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Every clearance here is in the API, with alerts when new ones post.