Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005713796

FEI Number

3005713796

Entity Name

G.TEC MEDICAL ENGINEERING GMBH

City/State/Country

SCHIEDLBERG Oberosterreich, AT

Establishment Address

14 SIERNINGSTRASSE, SCHIEDLBERG Oberosterreich 4521, AT

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

G.TEC MEDICAL ENGINEERING GMBH (Owner Number: 9084852)

Owner / Operator Contact Address

14 SIERNINGSTRASSE, --, SCHIEDLBERG, AT-NOTA 4521, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171669

PMA Number

N/A

All Registered Proprietary Names

g.HIamp cortiQ PRO g.Estim PRO g.ESTIM FES g.Nautilus PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2013-12-27
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-05
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2020-03-05
OLU	Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-05
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2018-05-11
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2020-11-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2020-11-27
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2017-08-03
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-08-03

Official Correspondent

CHRISTOPH GUGER

US Agent Details

Peter Hasslacher Email: newyork@wko.at Phone: (212) 4215250

Related Public Records

Same Entity

G.TEC MEDICAL ENGINEERING GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008008477	G.TEC MEDICAL ENGINEERING GMBH	Graz Steiermark, AT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K030403	Cefar Medical AB	CEFAR REHAB 2 AND REHAB 2 PRO	2003-07-17
K231440	Shenzhen Roundwhale Technology Co. , Ltd.	Combo Electrotherapy Device	2023-11-03

Similar Registrations

Registration Number	Establishment Name	Location
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3015614098	CGX, LLC	San Diego, CA, US
3020018	CADWELL INDUSTRIES, INC.	KENNEWICK, WA, US
3010762896	NEUROELECTRICS BARCELONA S.L.U.	Barcelona Catalonia, ES
9710486	LIFELINES LTD.	WOKING Surrey, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005713796. Last updated year: 2026. Please use registration number 3005713796 when referencing this establishment in official correspondence.