Duns Number:663211978
Device Description: The E-Stim II® Electro Acup/Micro is the most economical and easy-to-use portable electro- The E-Stim II® Electro Acup/Micro is the most economical and easy-to-use portable electro-therapy unit. New dual channel, portable, continuous frequency unit features Milli-amp (normal current) and Micro-amp (micro current) settings. Each channel also includes its own green LED light which displays power-on and frequency. Accessories include 2 sets of alligator clip wires, 9 volt battery, and instructions.
Catalog Number
ED3922
Brand Name
E-Stim II
Version/Model Number
ED3922
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
K050435,K050435
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
25513770-e2a7-4284-bcda-cd1788ea219a
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
August 04, 2016
Package DI Number
34897076720034
Quantity per Package
30
Contains DI Package
14897076720030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |