510(k) K213629

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

February 12, 2023

Date Received

November 17, 2021

Clearance Type

Traditional

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.