gtec.atG.Estim FES
G.tec Medical Engineering GmbH
G.TEC MEDICAL ENGINEERING GMBH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008008477 | 3008008477 | G.TEC MEDICAL ENGINEERING GMBH | 1 | N | 2026-01-01 | Herbersteinstrasse 60 Graz Steiermark AT 8020 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| EBCI11500 | g.Estim PRO - g.Estim PRO is a constant current, biphasic electrical stimulator intended for stimulation of neural tissue. g.Estim PRO has an applied part of type BF with connectors for bipolar stimulation electrodes (anode and cathode). The device is controlled by a computer via USB connection. It also has digital outputs for synchronization with other devices. A hand-switch allows you to perform stimulation manually. Alternatively, a foot-switch can be used to explicitly enable/disable stimulation. | +437251222400 | support@gtec.at |
| EBCI11700 | g.Estim FES - The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes as well as trains of such pulses. The applied part is galvanic isolated. The stimulator is powered by a combination of USB bus-power and battery power. The host computer must use Microsoft Windows. The stimulator is controlled via a software API that uses a USB connection. A host application can be situated on top of the API and can control the stimulator. | +437251222400 | support@gtec.at |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 299971 | 1500869770 | K200088 | g.Estim FES | IPF | 2020-10-29 |
| 299971 | 1956641048 | K191432 | cortiQ PRO | OLU | 2020-01-24 |
| 299971 | 1182286789 | K173684 | g.Estim PRO | GYC | 2018-05-04 |
| 299971 | 1054231225 | K171669 | g.Nautilus PRO | GWL | 2017-07-05 |
| 299971 | 1235808556 | K123255 | g.HIamp | GWL | 2012-12-20 |
Product Codes Associated With Registrations#
PMN#
CortiQ PRO
G.tec Medical Engineering GmbH
G.Estim PRO
G.tec Medical Engineering GmbH
G.Nautilus PRO
G.tec Medical Engineering GmbH
G.HLAMP
G.TEC MEDICAL ENGINEERING GMBH
G.USBAMP
G.TEC MEDICAL ENGINEERING GMBH
GUDID#
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2024-05-28
g.Estim FES - The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes as well as trains of such pulses. The applied part is galvanic isolated. The stimulator is powered by a combination of USB bus-power and battery power. The host computer must use Microsoft Windows. The stimulator is controlled via a software API that uses a USB connection. A host application can be situated on top of the API and can control the stimulator.
2020-12-01
cortiQ PRO - cortiQ PRO is a system that uses g.HIamp to map high-gamma broad band brain activity while running an experimental paradigm. The software helps to identify electrode positions coding differences in brain activity by means of experimental paradigm. cortiQ PRO performs the signal analysis in real-time and compares the high-gamma broad band activity during specific tasks. Then it performs a statistical analysis and visualizes electrodes coding the information that are statistically significant. It is abstracted from technical details of data acquisition, channel order and signal processing assuring robust and efficient measurements.
2020-03-06
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2021-04-16
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2021-04-16
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2021-04-16
g.Estim PRO - g.Estim PRO is a constant current, biphasic electrical stimulator intended for stimulation of neural tissue. g.Estim PRO has an applied part of type BF with connectors for bipolar stimulation electrodes (anode and cathode). The device is controlled by a computer via USB connection. It also has digital outputs for synchronization with other devices. A hand-switch allows you to perform stimulation manually. Alternatively, a foot-switch can be used to explicitly enable/disable stimulation.
2018-05-30
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.Nautilus PRO - The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
2017-11-23
g.HIamp - The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
2017-11-23
g.HIamp - The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
2017-11-23
g.HIamp - The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
2017-11-23
g.HIamp - The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
2020-03-30
g.HIamp - The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
2020-03-30
g.USBamp - The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG.
2017-04-12
g.USBamp - The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG.
2017-11-23
g.HIamp - The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
2017-04-12
g.HIamp - The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
2017-04-12
g.HIamp - The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
2017-04-12