FDA Product Code HCC: Device, Biofeedback
Leading manufacturers include Deepwell Dtx, Inc..
FDA 510(k) Cleared Device, Biofeedback Devices (Product Code HCC)
About Product Code HCC - Regulatory Context
510(k) Submission Activity
172 total 510(k) submissions under product code HCC since 1976, with 172 receiving FDA clearance (average review time: 176 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under HCC have taken an average of 268 days to reach a decision - up from 176 days historically. Manufacturers should account for longer review timelines in current project planning.
HCC devices are reviewed by the Neurology panel. Browse all Neurology devices →