510(k) K171481

MagVita TMS Therapy System by Tonica Elektronik A/S — Product Code OBP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 16, 2017
Date Received: May 19, 2017
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Transcranial Magnetic Stimulator
Device Class: Class II
Regulation Number: 882.5805
Review Panel: NE
Submission Type

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.

Other clearances by Tonica Elektronik A/S

K251125 — MagVenture TMS Therapy System (August 11, 2025)
K251119 — MagVenture TMS Therapy System (August 8, 2025)
K252032 — T65 (9016E061-) (July 30, 2025)
K230014 — MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, Mag (August 25, 2023)
K221544 — MagVenture TMS Atlas Neuro Navigation System (March 17, 2023)
K193006 — MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system (August 9, 2020)
K173620 — Mag Vita TMS Therapy System w/Theta Burst Stimulation (August 14, 2018)
K172667 — MagVita TMS Therapy w/MagPro R20 (October 5, 2017)
K171967 — MagVita TMS Therapy System (July 25, 2017)
K170114 — MagVita TMS Therapy - w/MagPro R20 (May 1, 2017)

Other clearances for product code OBP

K251653 — SPRY TMS Therapy System (0550) (February 20, 2026)
K251391 — BrainsWay Deep TMS System (November 7, 2025)
K250689 — CloudTMS Edge (September 14, 2025)
K251449 — BrainsWay Deep TMS System (September 13, 2025)
K243700 — Apollo TMS Therapy System (September 4, 2025)
K243539 — Apollo TMS Therapy System (August 18, 2025)
K251125 — MagVenture TMS Therapy System (August 11, 2025)
K251119 — MagVenture TMS Therapy System (August 8, 2025)
K252032 — T65 (9016E061-) (July 30, 2025)
K251210 — Ampa One System (AMPA-001) (June 27, 2025)