Duns Number:078497467
Device Description: Replacement Gel Pad for use with:1) SEM05 Vitalcontrol Mini TENS Arms & Legs Massage (Art. Replacement Gel Pad for use with:1) SEM05 Vitalcontrol Mini TENS Arms & Legs Massage (Art.- No 662.19)2) SEM05 Vitalcontrol Mini TENS LowerBack (Art.- No 662.23)
Catalog Number
-
Brand Name
Vitalcontrol
Version/Model Number
SEM05 Replacement Gel Pad (Art.-No.: 662.37)
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
a9eb14aa-f33c-4a3d-a97b-c181bf21b77a
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
May 29, 2017
Package DI Number
20853879007267
Quantity per Package
10
Contains DI Package
10853879007260
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 |