Duns Number:078497467
Device Description: Three Piece EMS Pad Set Arm-Leg & Sixpack- 1 x Sixpack Pad- 2 x Arm-Leg Pads- 2 x self-adh Three Piece EMS Pad Set Arm-Leg & Sixpack- 1 x Sixpack Pad- 2 x Arm-Leg Pads- 2 x self-adhesive gel film sets (for all 3 pads-16 x Gel Films)
Catalog Number
648.19
Brand Name
Vitalcontrol
Version/Model Number
SEM65
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
874360d4-e57b-4192-b625-817ff29b8368
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
November 25, 2019
Package DI Number
10850003500413
Quantity per Package
2
Contains DI Package
00850003500416
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 |