Data / Medical devices / Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (PCC): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (product code PCC, Class 2, 21 CFR 882.5891). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on April 16, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PCC
- Device class
- 2
- Regulation
- 882.5891
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| China | 3 |
| South Korea | 2 |
| Israel | 2 |
| Belgium | 1 |
| United States | 1 |
| Malaysia | 1 |
Makers of Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cefaly Technology | Liege, Belgium | Exporter to the US, Specification developer | 7 | July 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Nu Eyne Co., Ltd. | Guro-gu Seoul, South Korea | Manufacturer | 3 | November 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| NEUROLIEF Ltd. | Netanya Central, Israel | Complaint file establishment, Exporter to the US, Manufacturer | 2 | August 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Wat Medical Technology Inc. | Ningbo Zhejiang, China | Manufacturer | 2 | February 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hinge Health Inc. | San Francisco, CA, United States | Complaint file establishment, Specification developer | 1 | April 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Dongdixin Technology Co., Ltd. | SHENZHEN Guangdong, China | Manufacturer | 1 | June 17, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ybrain Inc. | Daejeon, South Korea | Manufacturer | 1 | June 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Inventec Appliances (Malaysia) Sdn Bhd | Bayan Lepas Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jdi Electronics Factory | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PM (partner Manufacturing) Ltd | Bar-lev Industrial Park Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.