Duns Number:689372738
Device Description: 1KHz Low and blood frequency electric current circulation. energy able to massage the musc 1KHz Low and blood frequency electric current circulation. energy able to massage the muscles with systaltic system and promote nervous With the double ball on Vroll , gives lowsedation frequency energy on the skin, eventually make the skin more elastic POINT 1 and have dramatic lifting effects.
Catalog Number
-
Brand Name
V-ROLL
Version/Model Number
IA-100VR
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)
-
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
07bafc86-2fd1-4a48-829f-056b8ea1e8e9
Public Version Date
September 30, 2022
Public Version Number
1
DI Record Publish Date
September 22, 2022
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 | 2 |