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The Magstim Company Ltd.: FDA-registered device maker in Carmarthenshire Wales, United Kingdom, 19 510(k) clearances

Name: The Magstim Company Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The Magstim Company Ltd. is registered with the FDA (registration 8021774) in Carmarthenshire Wales, United Kingdom. It lists 10 device types. The FDA files 19 510(k) clearances under its listings, the newest dated July 3, 2025. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8021774
FEI number: 3002808356
Address: Spring Gardens Whitland, Carmarthenshire Wales, United Kingdom, SA34 0HR
Owner or operator: The Magstim Company Ltd. (8021774)
Roles: Complaint file establishment, Manufacturer
First device listed: August 4, 2000
Registered through: 2026
Brand names listed: Air Film Coil, D70² Coil, Double 70mm MT Remote Coil, HORIZON® TMS Therapy System, HORIZON® Therapy System, Horizon 3 Inspire, Horizon 3 TMS Therapy System, Horizon TMS Therapy System and more

Devices it lists

Device	Product code	Class	Role	Source
Cap, Surgical	FYF	1	Manufacturer	accessdata.fda.gov
Device, Nerve Conduction Velocity Measurement	JXE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Electromagnetic Stimulator, Pain Relief	QPL	2	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Manufacturer	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve	ETN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	QCI	2	Manufacturer	accessdata.fda.gov
Transcranial Magnetic Stimulator	OBP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 3, 2025	K250286	Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)	QPL	Substantially Equivalent	The Magstim Company Limited	accessdata.fda.gov
March 17, 2025	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	The Magstim Company Limited	accessdata.fda.gov
August 30, 2024	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	The Magstim Company Limited	accessdata.fda.gov
September 14, 2021	K211389	Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation	OBP	Substantially Equivalent	Magstim Company, Ltd.	accessdata.fda.gov
April 3, 2019	K183376	HORIZON TMS Therapy System with Navigation	OBP	Substantially Equivalent	Magstim Company, Ltd.	accessdata.fda.gov
March 15, 2019	K182853	HORIZON TMS Therapy System	OBP	Substantially Equivalent	Magstim Company, Ltd.	accessdata.fda.gov
November 9, 2018	K181559	Neurosign V4 Intraoperative Nerve Monitor	PDQ	Substantially Equivalent	Magstim Company, Ltd.	accessdata.fda.gov
August 3, 2018	K180907	HORIZON TMS Therapy System	OBP	Substantially Equivalent	Magstim Company, Ltd.	accessdata.fda.gov
September 13, 2017	K171051	HORIZON Therapy System	OBP	Substantially Equivalent	Magstim Company, Ltd.	accessdata.fda.gov
March 10, 2017	K162935	Rapid2 Therapy System	OBP	Substantially Equivalent	Magstim Company, Ltd.	accessdata.fda.gov
May 8, 2015	K143531	Rapid Therapy System	OBP	Substantially Equivalent	Magstim Company Limited	accessdata.fda.gov
August 23, 2013	K130403	MAGSTIM DOUBLE 70-2 COIL	GWF	Substantially Equivalent	The Magstim Company , Ltd.	accessdata.fda.gov
December 8, 2008	K080499	MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00	GWF	Substantially Equivalent	The Magstim Company , Ltd.	accessdata.fda.gov
September 26, 2006	K060847	MAGSTIM 200-2	GWF	Substantially Equivalent	Magstim Company Us, LLC	accessdata.fda.gov
December 21, 2005	K051864	MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00	GWF	Substantially Equivalent	The Magstim Company , Ltd.	accessdata.fda.gov
December 14, 2005	K053141	NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800	ETN	Substantially Equivalent	The Magstim Company , Ltd.	accessdata.fda.gov
August 5, 1998	K980148	NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR	ETN	Substantially Equivalent	The Magstim Company , Ltd.	accessdata.fda.gov
May 14, 1997	K964869	NEUROSIGN 800, 8 CHANNEL MOTOR NERVE MONITOR	ETN	Substantially Equivalent	The Magstim Company , Ltd.	accessdata.fda.gov
November 24, 1992	K923056	NEUROSIGN MODEL 100	ETN	Substantially Equivalent	The Magstim Company , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 8, 2020	87063	Class II	Terminated	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 E	accessdata.fda.gov
June 23, 2020	85985	Class II	Terminated	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.	accessdata.fda.gov
March 23, 2020	85393	Class II	Terminated	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	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.	accessdata.fda.gov
October 25, 2018	81489	Class II	Ongoing	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.	accessdata.fda.gov
September 28, 2017	79577	Class II	Terminated	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 pat	Users manuals not supplied with 4800-00T US Rapid Therapy System	accessdata.fda.gov

Compare with other makers

Updated July 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.