FDA Product Code QJQ: Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety
Leading manufacturers include Neurovalens , Ltd., Neurovalens Limited and Neurofield, Inc..
FDA 510(k) Cleared Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety Devices (Product Code QJQ)
About Product Code QJQ - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code QJQ since 1977, with 19 receiving FDA clearance (average review time: 249 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under QJQ have taken an average of 106 days to reach a decision - down from 257 days historically, suggesting improved FDA processing for this classification.
QJQ devices are reviewed by the Neurology panel. Browse all Neurology devices →