Transcranial Magnetic Stimulation System For Post Traumatic Stress Disorder (Ptsd)

SIG · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5802

Classification

FDA Product Code: SIG
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 in brain areas outside cerebral cortex (e.g., cerebellum).

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown