Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
QCI · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5802
Classification
FDA Product Code
QCI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5802
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).