Duns Number:300916041
Device Description: The g.Estim FES is a programmable constant-current stimulator that can deliver electrical
Catalog Number
1170
Brand Name
g.Estim FES
Version/Model Number
TD 1.x
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
K200088
Product Code
GZI
Product Code Name
Stimulator, Neuromuscular, External Functional
Public Device Record Key
12d15024-df4d-46b7-85aa-93df45d9da6f
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
December 01, 2020
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 |