Duns Number:601204902
Device Description: Avid IF2 INTERFERENTIAL STIMULATION SYSTEM
Catalog Number
-
Brand Name
VQ OrthoCare
Version/Model Number
AV-IF19A
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
K183692
Product Code
NYN
Product Code Name
Stimulator, Electrical, Transcutaneous, For Arthritis
Public Device Record Key
f1479af2-ba0d-4976-b8bd-378b94cd2f10
Public Version Date
February 20, 2020
Public Version Number
1
DI Record Publish Date
February 12, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 170 |
2 | A medical device with a moderate to high risk that requires special controls. | 30 |