Duns Number:300916041
Device Description: g.Estim PRO is a constant current, biphasic electrical stimulator intended for stimulation 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.
Catalog Number
1150
Brand Name
g.Estim PRO
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173684
Product Code
GYC
Product Code Name
Electrode, Cortical
Public Device Record Key
975601ec-0643-4168-8b8f-a9e1d308ba81
Public Version Date
December 02, 2020
Public Version Number
3
DI Record Publish Date
May 30, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |