Duns Number:903359565
Device Description: NEUROTONUS PORTABLE TENS FES transcutaneous neuromuscular stimulator is a two-channel stim NEUROTONUS PORTABLE TENS FES transcutaneous neuromuscular stimulator is a two-channel stimulator with independent controls for current therapies used in: TENS (Transcutaneous Electrical Nerve Stimulation) and FES (Functional Electrical Stimulation).
Catalog Number
01002025
Brand Name
Ibramed
Version/Model Number
NEUROTONUS PORTABLE TENS FES
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K131923
Product Code
GZI
Product Code Name
Stimulator, Neuromuscular, External Functional
Public Device Record Key
19993e96-fd35-49b9-a711-87191108ec36
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 13, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |