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510(k) K233293

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® by Neurosigma, Inc. — Product Code QGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2024
Date Received
September 29, 2023
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.

Other clearances by Neurosigma, Inc.

  • DEN180041 — Monarch eTNS System (April 19, 2019)

Other clearances for product code QGL

  • K243289 — ADDNOX (BPSPM1) (January 16, 2025)
  • K232991 — BT-1000 (August 28, 2024)
  • K213629 — SMILE (February 12, 2023)
  • DEN180041 — Monarch eTNS System (April 19, 2019)