Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005545216

FEI Number

3005545216

Entity Name

TONICA ELEKTRONIK A/S

City/State/Country

FARUM Hovedstaden, DK

Establishment Address

LUCERNEMARKEN 15, FARUM Hovedstaden 3520, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TONICA ELEKTRONIK A/S (Owner Number: 9081660)

Owner / Operator Contact Address

LUCERNEMARKEN 15, --, FARUM, DK-NOTA 3520, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173620

PMA Number

N/A

All Registered Proprietary Names

MAGLITE MAGNETIC STIMULATOR MAGPRO MAGNETIC STIMULATOR MagPro Magnetic Stimulator MagVita TMS Therapy MagVenture TMS Therapy MagVita TMS Therapy System MagPro Magnetic Stimulator Coil for MagPro MagVenture TMS Therapy MagVita TMS Therapy MagVenture TMS Therapy for MDD with Comorbid Anxiety SAINT neuromodulation system MagVita TMS Therapy MagVenture TMS Therapy MagVita TMS Therapy System MagVenture TMS Therapy MagPro R20 MagVita TMS Therapy MagVenture TMS Therapy Express TMS MagVita TMS Therapy Xpress TMS MagVita TMS Therapy System w/ Theta Burst Stimulation Express TMS Therapy MagVenture TMS Therapy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2006-01-11
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2010-12-03
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2018-11-06
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2007-10-29
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2007-10-29
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2018-11-06
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2025-11-26
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	Neurology	Class 2	882.5802	2025-11-26
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2024-02-23
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2024-02-23
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2024-02-23
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2018-11-06
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2015-09-04
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2016-05-27
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	Neurology	Class 2	882.5802	2020-12-14
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2020-12-14
QPL	Electromagnetic Stimulator, Pain Relief	Neurology	Class 2	882.5890	2023-09-15
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2023-09-15
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2018-11-06

Official Correspondent

JAN KJOELLER

US Agent Details

Kerry Rome Business: MagVenture, Inc. Email: infousa@magventure.com Phone: (888) 6247764

Related Public Records

Same Entity

TONICA ELEKTRONIK A/S

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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9611252	NIHON KOHDEN CORP.	SHINJUKU-KU Tokyo, JP
3009959868	Ferry Machine Corporation	Little Ferry, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005545216. Last updated year: 2026. Please use registration number 3005545216 when referencing this establishment in official correspondence.