Duns Number:544559614
Device Description: The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient’s skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
Catalog Number
-
Brand Name
AUVON
Version/Model Number
EB10100B1
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
0cccff7a-0663-447c-a9a8-d5c9bfb8613a
Public Version Date
June 03, 2022
Public Version Number
1
DI Record Publish Date
May 26, 2022
Package DI Number
16971292002311
Quantity per Package
120
Contains DI Package
06971292002314
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. | 99 |