PCC
- Product code
- PCC
- Device name
- Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5891
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 18
FDA classification definition
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K254216 | 2026-04-16 | Hinge Health, Inc. | Enso for Migraine summary |
| K242719 | 2024-11-06 | Nu Eyne Co., Ltd. | ELEXIR 2.0 (ALLIVE3) summary |
| K234029 | 2024-07-18 | Cefaly Technology | CEFALY Connected - OTC, CEFALY Connected - Rx summary |
| K232749 | 2024-06-11 | Ybrain, Inc. | DOOPANG summary |
| K233751 | 2024-06-03 | Soterix Medical, Inc. | Milieve (YPS-301BD) summary |
| K230782 | 2024-02-26 | Wat Medical Technology, Inc. | TENS device-HeadaTerm 2 (Model: YF-HT2) summary |
Official FDA classification page: PCC
Classification and pathway per current FDA publications. Data from openFDA (CC0).