Duns Number:078497467
Device Description: Abdominal Toning Belt - EMS Electrical abdominal muscle stimulation
Catalog Number
-
Brand Name
Vitalcontrol
Version/Model Number
SEM36
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)
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
dd9dd492-fd02-4059-9987-16d61ecfce59
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
October 30, 2017
Package DI Number
10853879007451
Quantity per Package
3
Contains DI Package
00853879007454
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |