← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
PCC — Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.
DEVICE CLASS
Class II
REGULATION
21 CFR 882.5891
MEDICAL SPECIALTY
Neurology
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES
Recent clearances
K254216Hinge Health, Inc. · 510k2026-04-16
K242719Nu Eyne Co., Ltd. · 510k2024-11-06
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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