Cleared Traditional

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System?

K233293 · Neurosigma, Inc. · Neurology
Jan 2024
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K233293 is an FDA 510(k) clearance for the Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System?, a Transcutaneous Nerve Stimulator For Adhd (Class II — Special Controls, product code QGL), submitted by Neurosigma, Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 16, 2024, 109 days after receiving the submission on September 29, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5898.

Submission Details

510(k) Number K233293 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2023
Decision Date January 16, 2024
Days to Decision 109 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code QGL — Transcutaneous Nerve Stimulator For Adhd
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5898
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.