Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Neurology · 21 CFR 882.5891
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Recent MDR events
32 adverse event reports on file
- RELIVION MGMay 11, 2026InjuryNeurolief Inc.MW5187930
- CEFALYApr 3, 2026MalfunctionCefaly Technology3010760764-2026-00003
- CEFALYApr 3, 2026MalfunctionCefaly Technology3010188009-2026-00003
- CEFALYMar 9, 2026InjuryCefaly Technology3010760764-2026-00002
- CEFALYMar 9, 2026InjuryCefaly Technology3010188009-2026-00002
- CEFALYJan 29, 2026InjuryCefaly Technology3010188009-2026-00001
- STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINEDec 3, 2025InjuryCefaly TechnologyMW5179820
- RELIVIONSep 22, 2025InjuryNeurolief Ltd.MW5176411
- CEFALYNov 8, 2024InjuryCefaly TechnologyMW5162339
- CEFALYSep 25, 2024MalfunctionCefaly Technology3010188009-2024-00003
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
25 firms currently registered for this product code
Neurolief Inc.
Coral Springs, FL, US
Pm (partner Manufacturing) Ltd
Bar-lev Industrial Park Northern, IL
Ybrain Inc.
Daejeon, KR
Jdi Electronics Factory
Dongguan Guangdong, CN
Neurolief Ltd.
Netanya Central, IL
Wat Medical Technology Inc.
Ningbo Zhejiang, CN
Cefaly Technology
Liege, BE
Inventec Appliances (malaysia) Sdn Bhd
Bayan Lepas Pulau Pinang, MY
Nu Eyne Co., Ltd.
Guro-gu Seoul, KR
Hinge Health Inc.
San Francisco, CA, US
Compass Health Brands (corporate Office)
Middleburg Heights, OH, US
Shenzhen Dongdixin Technology Co., Ltd.
SHENZHEN Guangdong, CN
510(k) clearances
18 clearances for this product code
- Hinge Health, Inc.Apr 16, 2026
K254216 · Enso for Migraine
- Nu Eyne Co., Ltd.Nov 6, 2024
K242719 · ELEXIR 2.0 (ALLIVE3)
- Cefaly TechnologyJul 18, 2024
K234029 · CEFALY Connected - OTC, CEFALY Connected - Rx
- Ybrain, Inc.Jun 11, 2024
K232749 · DOOPANG
- Soterix Medical, Inc.Jun 3, 2024
K233751 · Milieve (YPS-301BD)
- Wat Medical Technology, Inc.Feb 26, 2024
K230782 · TENS device-HeadaTerm 2 (Model: YF-HT2)
- Cefaly TechnologyDec 13, 2022
K212071 · Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
- Neurolief , Ltd.Aug 2, 2021
K212106 · Relivion