Duns Number:544559614
Device Description: Adhesive electrodes are intended for use as the disposable, conductive adhesive interface Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient’s skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.
Catalog Number
-
Brand Name
AUVON
Version/Model Number
AS1080345
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NGX
Product Code Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Public Device Record Key
7eba9eb5-5107-4439-8972-5c4af1448fc9
Public Version Date
November 25, 2019
Public Version Number
1
DI Record Publish Date
November 15, 2019
Package DI Number
16971292000485
Quantity per Package
48
Contains DI Package
06971292000488
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |