510(k) DEN180041

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

April 19, 2019

Date Received

July 30, 2018

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Transcutaneous Nerve Stimulator For Adhd

Device Class

Class II

Regulation Number

882.5898

Review Panel

NE

Submission Type

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.