Magstim Inc.
Roseville, MN, US
MAGSTIM INC appears in FDA device records in Roseville, MN. FDA records list 27 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 27 510(k) clearances for Magstim Inc. between 1992 and 2025. The busiest year on record is 2023, with 3. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 2 |
| 2021 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | QPL | Substantially Equivalent | |
| K243869 | Horizon® 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) | OBP | Substantially Equivalent | |
| K241518 | Horizon® 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) | OBP | Substantially Equivalent | |
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro | OBP | Substantially Equivalent | |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | OBP | Substantially Equivalent | |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ | OBP | Substantially Equivalent | |
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation | OBP | Substantially Equivalent | |
| K203684 | Neurosign V4 Intraoperative Nerve Monitor | PDQ | Substantially Equivalent | |
| K183376 | HORIZON TMS Therapy System with Navigation | OBP | Substantially Equivalent | |
| K182853 | HORIZON TMS Therapy System | OBP | Substantially Equivalent | |
| K181559 | Neurosign V4 Intraoperative Nerve Monitor | PDQ | Substantially Equivalent | |
| K180907 | HORIZON TMS Therapy System | OBP | Substantially Equivalent | |
| K171051 | HORIZON Therapy System | OBP | Substantially Equivalent | |
| K162935 | Rapid2 Therapy System | OBP | Substantially Equivalent | |
| K143531 | Rapid Therapy System | OBP | Substantially Equivalent | |
| K130403 | MAGSTIM DOUBLE 70-2 COIL | GWF | Substantially Equivalent | |
| K083242 | NEUROSIGN AVALANCHE MOTOR NERVE MONITOR | ETN | Substantially Equivalent | |
| K080499 | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 | GWF | Substantially Equivalent | |
| K071349 | NEUROSIGN LARYNGEAL ELECTRODES | ETN | Substantially Equivalent | |
| K051864 | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 | GWF | Substantially Equivalent | |
| K053141 | NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 | ETN | Substantially Equivalent | |
| K991583 | NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR | ETN | Substantially Equivalent | |
| K980148 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | ETN | Substantially Equivalent | |
| K964869 | NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR | ETN | Substantially Equivalent | |
| K945799 | NEUROSIGN 100 IMPEDANCE METER | ETN | Substantially Equivalent | |
| K951641 | NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR | ETN | Substantially Equivalent | |
| K923056 | NEUROSIGN MODEL 100 | ETN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3017666517 | 3001090553 | MAGSTIM INC | 78 Centennial Loop, Eugene, OR 97401 US | 2026 | |
| 3011755356 | 3011755356 | Magstim Inc. | 1626 Terrace Drive, Roseville, MN 55113 US | 2026 | No device listings on this registration |
| 8021774 | 3002808356 | THE MAGSTIM COMPANY LTD. | Spring Gardens, Carmarthenshire Wales SA34 0HR GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FYFCap, Surgical
- JXEDevice, Nerve Conduction Velocity Measurement
- QPLElectromagnetic Stimulator, Pain Relief
- GWQFull-Montage Standard Electroencephalograph
- OUGMedical Device Data System
- PDQNeurosurgical Nerve Locator
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph
- GWFStimulator, Electrical, Evoked Response
- IPFStimulator, Muscle, Powered
- ETNStimulator, Nerve
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- OBPTranscranial Magnetic Stimulator
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0869-2021 | Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures. | A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set to 240V (European Standard), versus 120V requirement for the United States and Canada. 2. Fuses installed in the Power Entry Module (PEM) 2xT315mAL (240V Standard), versus the 2xT630mAL requirement for a 120V mains supply. | Class II | Terminated | |
| Z-2884-2020 | Neurosign V4 Intraoperative Nerve monitor family of devices. | Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables. | Class II | Terminated | |
| Z-1966-2020 | Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail. | Class II | Terminated | |
| Z-1965-2020 | Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail. | Class II | Terminated | |
| Z-0836-2019 | HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) | A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm. | Class II | Open, Classified | |
| Z-1352-2018 | Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | Users manuals not supplied with 4800-00T US Rapid Therapy System | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain