Duns Number:544559614
Device Description: Transcutaneous Electrical Nerve Stimulation (TENS):To be used for temporary relief of pain Transcutaneous Electrical Nerve Stimulation (TENS):To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upperextremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.Powered Muscle Stimulation (PMS):It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Catalog Number
-
Brand Name
AUVON
Version/Model Number
AS8019
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
005db508-39c8-4a24-b4bc-f7f17b49406a
Public Version Date
September 29, 2022
Public Version Number
1
DI Record Publish Date
September 21, 2022
Package DI Number
16971292000799
Quantity per Package
48
Contains DI Package
06971292000792
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 |