Transcutaneous Nerve Stimulator For Adhd

QGL · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5898

Classification

FDA Product Code: QGL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.5898
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 4

Source

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