NEXSTIM PLC

FDA Device Registration & Listing · Helsinki Uusimaa, FI · Registration 3007147067

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
3007147067
FEI Number
3007147067
Entity Name
NEXSTIM PLC
City/State/Country
Helsinki Uusimaa, FI
Establishment Address
Elimaenkatu 9B, Helsinki Uusimaa 00510, FI
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Nexstim Plc (Owner Number: 10031252)
Owner / Operator Contact Address
Elimaenkatu 9B, Helsinki, FI-18 00510, FI
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K091457
PMA Number
N/A

All Registered Proprietary Names

Nexstim Navigated Brain Therapy (NBT) System 2 Nexstim Navigated Brain Therapy System (NBT) 2 NBS 6 Nexstim NBS system 6 Nexstim NBS System 6 NBS 6 Nexstim Navigated Brain Stimulation (NBS) 6 System Nexstim Navigated Brain Stimulation (NBS) 6 System NBS 6 Nexstim NBS System 6 Nexstim NBS System 5 Nexstim NexSpeech NBS 5+ Nexstim Navigated Brain Stimulation System Nexstim NBS System 4 NexSpeech Nexstim NBS System 6 NBS 6 Nexstim Nexstim eXimia NBS System eXimia Navigated Brain Stimulation (NBS) Nexstim NBS System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2017-12-08
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2017-12-08
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2017-12-08
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2017-12-08
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2019-10-22
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2019-10-22
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2019-10-22
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2019-10-22
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2026-04-08
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2026-04-08
QFF Electromechanical Arm For A Transcranial Magnetic Stimulation System Neurology Class 2 882.5805 2026-04-08
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2026-04-08
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2026-04-08
OBP Transcranial Magnetic Stimulator Neurology Class 2 882.5805 2026-04-08
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2026-04-08
QCI Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder Neurology Class 2 882.5802 2026-04-08
QFF Electromechanical Arm For A Transcranial Magnetic Stimulation System Neurology Class 2 882.5805 2026-04-08
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2012-07-02
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2012-07-02
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2012-07-02
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2010-01-07
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2010-01-07
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2010-01-07

Official Correspondent

Anneka Kruuti

US Agent Details

Mark Cox Business: Nexstim Inc. Email: mark.cox@nexstim.com Phone: (817) 8329239

Related Public Records

Same Entity

Nexstim Plc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K880088 Cadwell Laboratories, Inc. CADWELL EXCEL 1988-05-04
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
K010427 Walter Lorenz Surgical, Inc. LORENZ FIDUCAIL SCREW 2001-03-15
K812744 Progress Mankind Technology LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER 1981-12-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012 Medtronic Navigation, Inc 2
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007 Stryker Instruments Div. of Stryker Corporation 2
Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007147067. Last updated year: 2026. Please use registration number 3007147067 when referencing this establishment in official correspondence.
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