Duns Number:791468734
Device Description: Transcutaneous Electrical Stimulation Electrode
Catalog Number
-
Brand Name
WalkAide 1.25 Premium Electrodes - pkg of 4
Version/Model Number
20-0521
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
298c5a1d-47e0-4217-90f9-5582027dfc95
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
August 16, 2016
Package DI Number
10858184006106
Quantity per Package
10
Contains DI Package
00858184006109
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |