OBP · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5805
Classification
FDA Product Code
OBP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5805
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.