Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

QGT · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5899

Classification

FDA Product Code: QGT
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5899
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.

Market data

Cleared 510(k) submissions: 7
Registered establishments: 2

Source

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