FDA.reportPublic FDA data

g.Estim FES

Primary DI
EBCI11700
Brand
g.Estim FES
Company
g.tec medical engineering GmbH
Model
TD 1.x
Catalog number
1170
Device description
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.
Published
2020-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200088000g.Estim FESG.Tec Medical Engineering GmbH2020-10-29IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBCI11700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not a portable wearable device such as a wristband. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+437251222400support@gtec.at

Regulatory Flags#

DUNS number
300916041
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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EBCI5710PRO0g.Nautilus PRO16 FLEXIBLE channels5710PRO2021-04-16
EBCI5720PRO0g.Nautilus PRO8 FLEXIBLE channels5720PRO2021-04-16
EBCI11500g.Estim PRO111502018-05-30
EBCI5100PRO0g.Nautilus PRO32-Channel5100PRO2017-11-23
EBCI5101PRO0g.Nautilus PRO32-Channel-CSP5101PRO2017-11-23
EBCI5110PRO0g.Nautilus PRO16-Channel5110PRO2017-11-23
EBCI5111PRO0g.Nautilus PRO16-Channel-mB5111PRO2017-11-23
EBCI5112PRO0g.Nautilus PRO16-Channel-rX5112PRO2017-11-23
EBCI5120PRO0g.Nautilus PRO8-Channel5120PRO2017-11-23
EBCI5200PRO0g.Nautilus PRO32-Channel Sahara5200PRO2017-11-23
EBCI5201PRO0g.Nautilus PRO32-Channel-CSP Sahara5201PRO2017-11-23
EBCI5210PRO0g.Nautilus PRO16-Channel Sahara5210PRO2017-11-23
EBCI5211PRO0g.Nautilus PRO16-Channel-mB Sahara5211PRO2017-11-23
EBCI5212PRO0g.Nautilus PRO16-Channel-rX Sahara5212PRO2017-11-23
EBCI5220PRO0g.Nautilus PRO8-Channel Sahara5220PRO2017-11-23
EBCI7001US0g.HIamp80-Channel Amplifier70012017-11-23
EBCI7002US0g.HIamp144-Channel Amplifier70022017-11-23

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Primary DI, Brand, Company table
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