Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
The Transcutaneous Electrical Nerve Stimulator for Migraine is a device that applies an electrical current to a patient's cranium through electrodes placed on the skin to prevent or treat migraine headaches. It falls under the Neurology medical specialty and is classified as a Class 2 device under regulation 882.5891, requiring 510(k) premarket notification. This type of device provides a non-pharmacological option for migraine management. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PCC
- Device Class
- FDA class 2
- Regulation Number
- 882.5891
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K254216 | Enso for Migraine | Apr 16, 2026 | Substantially Equivalent | Hinge Health, Inc. |
| K242719 | ELEXIR 2.0 (ALLIVE3) | Nov 06, 2024 | Substantially Equivalent | Nu Eyne Co., Ltd. |
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Jul 18, 2024 | Substantially Equivalent | Cefaly Technology |
| K232749 | DOOPANG | Jun 11, 2024 | Substantially Equivalent | Ybrain, Inc. |
| K233751 | Milieve (YPS-301BD) | Jun 03, 2024 | Substantially Equivalent | Soterix Medical, Inc. |
| K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | Feb 26, 2024 | Substantially Equivalent | Wat Medical Technology, Inc. |
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx | Dec 13, 2022 | Substantially Equivalent | Cefaly Technology |
| K212106 | Relivion | Aug 02, 2021 | Substantially Equivalent | Neurolief , Ltd. |
| K211380 | Elexir | Jul 30, 2021 | Substantially Equivalent | Nu Eyne Co., Ltd. |
| K210364 | Migraine Tens Digital Pain Reliever | Jun 17, 2021 | Substantially Equivalent | Shenzhen Dongdixin Technology Co., Ltd. |
| K203419 | Relivion | Feb 16, 2021 | Substantially Equivalent | Neurolief , Ltd. |
| K201895 | Cefaly Dual | Sep 29, 2020 | Substantially Equivalent | Cefaly Technology |
| K192773 | ALLIVE | Dec 06, 2019 | Substantially Equivalent | Nu Eyne Co., Ltd. |
| K172450 | TENS device-HeadaTerm, eEspress | Sep 13, 2018 | Substantially Equivalent | Wat Medical Technology (Ningbo) Co., Ltd. |
| K173006 | Cefaly Dual | Nov 28, 2017 | Substantially Equivalent | Cefaly Technology |
| K171446 | Cefaly Acute | Sep 15, 2017 | Substantially Equivalent | Cefaly Technology |
| K160237 | Cefaly | Mar 04, 2016 | Substantially Equivalent | Cefaly Technology |
| DEN120019 | CEFALY | Mar 11, 2014 | Unknown | Stx-Med Sprl |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.