Duns Number:080339637
Device Description: Tens Meter- including 2 electrode cables, electrodes, charger, plastic holder, usb cable a Tens Meter- including 2 electrode cables, electrodes, charger, plastic holder, usb cable and one bottle of 30ct. Cyclobenzaprine 10mg
Catalog Number
-
Brand Name
CycloTens Starter Pak
Version/Model Number
50053A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133979,K133979,K133979
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
ae90a744-ed7d-4065-a164-2314ea9a7bc0
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
July 24, 2017
Package DI Number
20370914012005
Quantity per Package
120
Contains DI Package
00370914012001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Box