Cleared Traditional

MagVenture TMS Therapy System

K251125 · Tonica Elektronik A/S · Neurology
Aug 2025
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K251125 is an FDA 510(k) clearance for the MagVenture TMS Therapy System, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on August 11, 2025, 122 days after receiving the submission on April 11, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K251125 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2025
Decision Date August 11, 2025
Days to Decision 122 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OBP — Transcranial Magnetic Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5805
Definition A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.