THE MAGSTIM COMPANY LTD.

FDA Device Registration & Listing · Carmarthenshire Wales, GB · Registration 8021774

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8021774
FEI Number
3002808356
Entity Name
THE MAGSTIM COMPANY LTD.
City/State/Country
Carmarthenshire Wales, GB
Establishment Address
Spring Gardens, Whitland, Carmarthenshire Wales SA34 0HR, GB
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
The Magstim Company Ltd. (Owner Number: 8021774)
Owner / Operator Contact Address
Spring Gardens, Whitland, GB-WLS SA340HR, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K080499
PMA Number
N/A

All Registered Proprietary Names

Horizon 3 Inspire Mute Sensor Magstim Connect Magstim TMS Patient Caps Size Large Magstim TMS Patient Caps Size Extra Large Magstim TMS Patient Caps Size Small Magstim TMS Patient Caps Size Medium Mute Sensor Mute Sensor HORIZON® Therapy System D70² Coil Magstim Super Rapid² Magstim Rapid² Magstim 200² Horizon TMS Therapy System with Navigation Magstim Rapid² Therapy System Air Film Coil Double 70mm MT Remote Coil Neurosign V4 Intraoperative Nerve Monitor Magstim Double 70mm Air Film Coil MODEL 3910-00

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Neurology Class 2 882.5802 2026-04-27
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2026-04-27
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Neurology Class 2 882.5802 2024-10-30
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2024-10-30
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2011-02-24
OUG Medical Device Data System General Hospital Class 1 880.6310 2016-09-23
FYF Cap, Surgical General, Plastic Surgery Class 1 878.4040 2022-01-18
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2012-06-11
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2011-02-24
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2017-09-18
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2013-11-15
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2009-07-23
JXE Device, Nerve Conduction Velocity Measurement Neurology Class 2 882.1550 2000-08-04
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2000-08-04
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2019-04-26
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2017-03-16
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2018-11-14
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2018-11-14
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2011-02-24

Official Correspondent

Heather Pendlebury

US Agent Details

Jennifer Maahs Business: Magstim Inc. Email: jmaahs@welcony.com Phone: (651) 2394810

Related Public Records

Same Entity

The Magstim Company Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017666517 MAGSTIM INC Eugene, OR, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243700 Mag & More GmbH Apollo TMS Therapy System 2025-09-04
K231926 Neuronetics, Inc. NeuroStar Advanced Therapy System (All previously cleared models) 2024-03-22
K833646 Edward Weck, Inc. PULSATRON NERVE LOCATOR/STIMULATOR 1984-02-10
K150005 Ndi Medical, LLC Checkpoint, Checkpoint Head & Neck 2015-02-19
K880088 Cadwell Laboratories, Inc. CADWELL EXCEL 1988-05-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.
Z-0024-2020 Stryker Instruments Div. of Stryker Corporation 2
C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8021774. Last updated year: 2026. Please use registration number 8021774 when referencing this establishment in official correspondence.
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