Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache

OKP · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5808

Classification

FDA Product Code: OKP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5808
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache.

Market data

Cleared 510(k) submissions: 6
Registered establishments: 1

Source

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