FDA product code PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
PCC is the FDA product code for stimulator, nerve, electrical, transcutaneous, for migraine. It is a Class II device, regulated under 21 CFR 882.5891 and reviewed by the Neurology panel. FDA has cleared 17 510(k) submissions under PCC, 7 in the last five years, from 9 different applicants. The average 510(k) review took 165 days (median 108); 162 days on average over the last three years. 1 De Novo request was granted under it.
Definition
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Device class | Class II |
| Regulation | 21 CFR 882.5891 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for PCC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 92 |
| 2018 | 1 | 395 |
| 2019 | 1 | 67 |
| 2020 | 1 | 83 |
| 2021 | 4 | 83 |
| 2022 | 1 | 529 |
| 2024 | 5 | 216 |
| 2026 | 1 | 108 |
Compare with all 510(k) review times · Search every PCC clearance
Top PCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cefaly Technology | 6 | 2024-07-18 |
| Nu Eyne Co., Ltd. | 3 | 2024-11-06 |
| Neurolief , Ltd. | 2 | 2021-08-02 |
| Hinge Health, Inc. | 1 | 2026-04-16 |
| Ybrain, Inc. | 1 | 2024-06-11 |
4 more applicants have PCC clearances. See the full list in Caduvo.
Most recent PCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254216 | Hinge Health, Inc. | Enso for Migraine | 2026-04-16 | 108 |
| K242719 | Nu Eyne Co., Ltd. | ELEXIR 2.0 (ALLIVE3) | 2024-11-06 | 57 |
| K234029 | Cefaly Technology | CEFALY Connected - OTC, CEFALY Connected - Rx | 2024-07-18 | 211 |
| K232749 | Ybrain, Inc. | DOOPANG | 2024-06-11 | 277 |
| K233751 | Soterix Medical, Inc. | Milieve (YPS-301BD) | 2024-06-03 | 194 |
Recalls for PCC devices
openFDA lists no recalls for product code PCC.
Frequently asked questions
What is FDA product code PCC?
PCC is the FDA product code for stimulator, nerve, electrical, transcutaneous, for migraine. It is a Class II device, regulated under 21 CFR 882.5891 and reviewed by the Neurology panel.
What device class is PCC?
Class II, regulation 21 CFR 882.5891. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCC?
Across 17 cleared submissions the average was 165 days from receipt to decision (median 108).
Which companies have the most PCC clearances?
Cefaly Technology (6); Nu Eyne Co., Ltd. (3); Neurolief , Ltd. (2); Hinge Health, Inc. (1); Ybrain, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCC
- Run a recall and safety report across every PCC manufacturer
- Watch product code PCC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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