FDA Product Code OBP: Transcranial Magnetic Stimulator
A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.
Leading manufacturers include Tonica Elektronik A/S, Brainsway , Ltd. and Mag & More GmbH.
FDA 510(k) Cleared Transcranial Magnetic Stimulator Devices (Product Code OBP)
About Product Code OBP - Regulatory Context
510(k) Submission Activity
64 total 510(k) submissions under product code OBP since 2008, with 63 receiving FDA clearance (average review time: 158 days).
Submission volume has increased in recent years - 18 submissions in the last 24 months compared to 13 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OBP have taken an average of 194 days to reach a decision - up from 144 days historically. Manufacturers should account for longer review timelines in current project planning.
OBP devices are reviewed by the Neurology panel. Browse all Neurology devices →