Duns Number:544559614
Device Description: To be used for temporary relief of pain associated with sore and aching muscles in the sho To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Catalog Number
-
Brand Name
AUVON
Version/Model Number
AS8012-013
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
5b5ad3ce-4e54-4579-aeda-27db33201153
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
August 27, 2019
Package DI Number
16971292000478
Quantity per Package
48
Contains DI Package
06971292000464
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 |