Duns Number:078497467
Device Description: Tens Device Knee / Elbow 2 in 1For the temporary relief of pain associated with sore and a Tens Device Knee / Elbow 2 in 1For the temporary relief of pain associated with sore and aching muscles
Catalog Number
-
Brand Name
Vitalcontrol
Version/Model Number
SEM50 (Art.-No.: 666.69)
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
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
8c4028b2-3b1e-4a1d-95b8-d5ea1f9993b0
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
May 15, 2017
Package DI Number
10853879007093
Quantity per Package
4
Contains DI Package
00853879007096
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 |