Duns Number:932471881
Catalog Number
-
Brand Name
Flex-TENS Retail 022017
Version/Model Number
FLET0001R02
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 16, 2017
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071869
Product Code
LIH
Product Code Name
Interferential Current Therapy
Public Device Record Key
86243097-239f-4cdd-9f5a-4a76ae2fdea1
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
May 16, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 94 |