Duns Number:342585299
Device Description: Indications for UseThe VIASURE is intended for :• Relief of minor muscle aches and pains• Indications for UseThe VIASURE is intended for :• Relief of minor muscle aches and pains• Temporary increase in local blood circulation• Activation of connective tissue
Catalog Number
1000015
Brand Name
VIASURE
Version/Model Number
OW100-US
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
c18d021d-0351-475b-9a89-f4867f440435
Public Version Date
July 09, 2021
Public Version Number
1
DI Record Publish Date
July 01, 2021
Package DI Number
04260484571694
Quantity per Package
1
Contains DI Package
04260484571687
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Caton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |