FDA Product Code PCC: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.
Leading manufacturers include Cefaly Technology, Neurolief , Ltd. and Nu Eyne Co., Ltd..
FDA 510(k) Cleared Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Devices (Product Code PCC)
About Product Code PCC - Regulatory Context
510(k) Submission Activity
18 total 510(k) submissions under product code PCC since 2014, with 17 receiving FDA clearance (average review time: 181 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for PCC submissions have been consistent, averaging 169 days recently vs 186 days historically.
PCC devices are reviewed by the Neurology panel. Browse all Neurology devices →