Duns Number:529966489
Device Description: Flexible and easy to fit electrode can be applied to every contour of the human body. You Flexible and easy to fit electrode can be applied to every contour of the human body. You can use the electrodes many times because of its reliable long lasting gel. The unique gel used with the electrode is very cost effective and provides excellent current distribution on the total electrode. Optimal distribution of current . Give patient comfort during stimulation.
Catalog Number
-
Brand Name
alegriaCare
Version/Model Number
50*50
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 30, 2020
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)
-
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
93e0ad5b-333d-4a2c-a629-952aaabc7876
Public Version Date
April 25, 2022
Public Version Number
3
DI Record Publish Date
August 30, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 123 |
| U | Unclassified | 2 |