Cleared Traditional

Apollo TMS Therapy System

K232639 · Mag & More GmbH · Neurology
May 2024
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K232639 is an FDA 510(k) clearance for the Apollo TMS Therapy System, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Mag & More GmbH (Munich, DE). The FDA issued a Cleared decision on May 24, 2024, 268 days after receiving the submission on August 30, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K232639 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2023
Decision Date May 24, 2024
Days to Decision 268 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.