PCC — Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Class II
FDA product code PCC covers "Stimulator, Nerve, Electrical, Transcutaneous, For Migraine", a Class II medical device regulated under 21 CFR 882.5891. Submissions are reviewed by the Neurology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PCC
- Device Class
- Class II
- Regulation Number
- 882.5891
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254216 | hinge health | Enso for Migraine | April 16, 2026 |
| K242719 | nu eyne co | ELEXIR 2.0 (ALLIVE3) | November 6, 2024 |
| K234029 | cefaly technology | CEFALY Connected - OTC, CEFALY Connected - Rx | July 18, 2024 |
| K232749 | ybrain | DOOPANG | June 11, 2024 |
| K233751 | soterix medical | Milieve (YPS-301BD) | June 3, 2024 |
| K230782 | wat medical technology | TENS device-HeadaTerm 2 (Model: YF-HT2) | February 26, 2024 |
| K212071 | cefaly technology | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefal | December 13, 2022 |
| K212106 | neurolief | Relivion | August 2, 2021 |
| K211380 | nu eyne co | Elexir | July 30, 2021 |
| K210364 | shenzhen dongdixin technology co | Migraine Tens Digital Pain Reliever | June 17, 2021 |
| K203419 | neurolief | Relivion | February 16, 2021 |
| K201895 | cefaly technology | Cefaly Dual | September 29, 2020 |
| K192773 | nu eyne co | ALLIVE | December 6, 2019 |
| K172450 | wat medical technology (ningbo) co | TENS device-HeadaTerm, eEspress | September 13, 2018 |
| K173006 | cefaly technology | Cefaly Dual | November 28, 2017 |
| K171446 | cefaly technology | Cefaly Acute | September 15, 2017 |
| K160237 | cefaly technology | Cefaly | March 4, 2016 |
| DEN120019 | stx-med sprl | CEFALY | March 11, 2014 |