Product code PCC
- Device name
- Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5891
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254216 | Enso for Migraine | Hinge Health, Inc. | 2026-04-16 |
| K242719 | ELEXIR 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. | 2024-11-06 |
| K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | Cefaly Technology | 2024-07-18 |
| K232749 | DOOPANG | Ybrain, Inc. | 2024-06-11 |
| K233751 | Milieve (YPS-301BD) | Soterix Medical, Inc. | 2024-06-03 |
| K230782 | TENS device-HeadaTerm 2 (Model: YF-HT2) | Wat Medical Technology, Inc. | 2024-02-26 |
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx | Cefaly Technology | 2022-12-13 |
| K212106 | Relivion | Neurolief , Ltd. | 2021-08-02 |
| K211380 | Elexir | Nu Eyne Co., Ltd. | 2021-07-30 |
| K210364 | Migraine Tens Digital Pain Reliever | Shenzhen Dongdixin Technology Co., Ltd. | 2021-06-17 |
| K203419 | Relivion | Neurolief , Ltd. | 2021-02-16 |
| K201895 | Cefaly Dual | Cefaly Technology | 2020-09-29 |
| K192773 | ALLIVE | Nu Eyne Co., Ltd. | 2019-12-06 |
| K172450 | TENS device-HeadaTerm, eEspress | Wat Medical Technology (Ningbo) Co., Ltd. | 2018-09-13 |
| K173006 | Cefaly Dual | Cefaly Technology | 2017-11-28 |
| K171446 | Cefaly Acute | Cefaly Technology | 2017-09-15 |
| K160237 | Cefaly | Cefaly Technology | 2016-03-04 |
| DEN120019 | CEFALY | Stx-Med Sprl | 2014-03-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800051500502 | ELEXIR 2.0 | Nu Eyne Co., Ltd. | 2026-04-27 |
| 00850045950149 | Enso | Hinge Health, Inc. | 2026-04-24 |
| 08800020403032 | DOOPANG | Ybrain Inc. | 2026-03-10 |
| 16971760280005 | HeadaTerm | WAT Medical Technology Inc. | 2025-08-22 |
| 06971760280138 | HeadaTerm | WAT Medical Technology Inc. | 2025-08-22 |
| 00023601261007 | AccuRelief | Drive Devilbiss Healthcare | 2024-12-17 |
| 30023601261008 | AccuRelief | COMPASS HEALTH BRANDS CORP. | 2024-12-17 |
| 00092237626658 | TENS 7000 | Drive Devilbiss Healthcare | 2024-10-30 |
| 30092237626659 | TENS 7000 | COMPASS HEALTH BRANDS CORP. | 2024-10-30 |
| 08800051500199 | ELEXIR | Nu Eyne Co., Ltd. | 2023-08-04 |
| 05425018850334 | Cefaly® | Cefaly Technology SPRL | 2022-12-22 |
| 05425018850297 | Cefaly® | Cefaly Technology SPRL | 2022-12-22 |
| 05425018850280 | Cefaly® | Cefaly Technology SPRL | 2022-12-22 |
| 06971760285003 | HeadaTerm | WAT Medical Technology Inc. | 2022-08-23 |
| 16971760285000 | HeadaTerm | WAT Medical Technology Inc. | 2022-08-23 |
| 07290018393130 | Relivion MG PMI Physician Interface | NEUROLIEF LTD | 2021-12-19 |
| 07290018393147 | Relivion MG App | NEUROLIEF LTD | 2021-12-19 |
| 17290018393014 | Relivion | NEUROLIEF LTD | 2021-12-05 |
| 07290018393000 | Relivion | NEUROLIEF LTD | 2021-12-05 |
| 07290018393017 | Relivion | NEUROLIEF LTD | 2021-12-05 |
| 17290018393113 | Relivion | NEUROLIEF LTD | 2021-12-05 |
| 06971760280022 | HeadaTerm | WAT Medical Technology Inc. | 2021-11-30 |
| 05425018850174 | Cefaly® | Cefaly Technology SPRL | 2021-07-13 |
| 05425018850181 | Cefaly® | Cefaly Technology SPRL | 2021-07-13 |
| 05425018850310 | Cefaly® | Cefaly Technology SPRL | 2021-07-13 |
| 05425018850303 | Cefaly® | Cefaly Technology SPRL | 2021-07-13 |
| 05425018850273 | Cefaly® | Cefaly Technology SPRL | 2021-05-17 |
| 08800051500021 | ALLIVE | Nu Eyne Co., Ltd. | 2021-03-22 |
| 05425018850266 | Cefaly® | Cefaly Technology SPRL | 2017-11-29 |
| 05425018850044 | Cefaly® | Cefaly Technology SPRL | 2016-09-17 |