Duns Number:789127011
Device Description: MaxTens 1k - Analog Tens Unit
Catalog Number
-
Brand Name
Bio Protech
Version/Model Number
MaxTens 1k
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"
Yes
For Single-Use
Yes
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
K073438,K073438,K073438
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
1e3414e8-a885-4875-a2ab-e9df36fdf842
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
June 15, 2016
Package DI Number
00817120020029
Quantity per Package
8
Contains DI Package
00817120020012
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 103 |