FDA.reportPublic FDA data

510(k) K260189

Device
MagVenture Accelerated TMS (aTMS) Therapy System
Applicant
Tonica Elektronik A/S
510(k) number
K260189
Product code
OBP
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-22
Date received
2026-01-22
Regulation
882.5805
Classification name
Transcranial Magnetic Stimulator
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jan Kjøller
Address
Lucernemarken 15 Farum DK DK-3520 DK-3520

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OBP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH2026-05-22
K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj2026-03-20
K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj2026-03-20
K251653SPRY TMS Therapy System (0550)Soterix Medical, Inc.2026-02-20
K251391BrainsWay Deep TMS SystemBrainsway , Ltd.2025-11-07
K250689CloudTMS EdgeTeleemg, LLC2025-09-14
K251449BrainsWay Deep TMS SystemBrainsway , Ltd.2025-09-13
K243700Apollo TMS Therapy SystemMag & More GmbH2025-09-04
K243539Apollo TMS Therapy SystemMag & More GmbH2025-08-18
K251125MagVenture TMS Therapy SystemTonica Elektronik A/S2025-08-11
K251119MagVenture TMS Therapy SystemTonica Elektronik A/S2025-08-08
K252032T65 (9016E061-)Tonica Elektronik A/S2025-07-30
K251210Ampa One System (AMPA-001)Neuromodulatory Devices & Applications2025-06-27
K243460Ultimate rTMSBrain Ultimate, Inc.2025-04-17
K243869Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System (Horizon 3.0 with StimGuide Pro); Horizon® 3.0 TMS Therapy System (Horizon 3.0)The Magstim Company Limited2025-03-17