Product code QGL

Device name

Transcutaneous Nerve Stimulator For Adhd

Medical specialty

Neurology

Device class

2

Regulation number

882.5898

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset