Duns Number:544559614
Device Description: TENS:The device is designed to be used for temporary relief of pain associated with sore a TENS:The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.EMS:The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Catalog Number
-
Brand Name
AUVON
Version/Model Number
AS1080
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
fa2622ec-128c-4163-a069-8d08f477fb04
Public Version Date
August 05, 2022
Public Version Number
1
DI Record Publish Date
July 28, 2022
Package DI Number
16971292000775
Quantity per Package
48
Contains DI Package
06971292000778
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 |