Duns Number:658608864
Device Description: Model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator Model WL-2407Rx is a portable, battery-powered, transcutaneous electrical nerve stimulator (TENS device) that is intended for symptomatic relief of chronic intractable pain.
Catalog Number
-
Brand Name
WELL-LIFE
Version/Model Number
WL-2407Rx
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 07, 2019
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K080304
Product Code
LIH
Product Code Name
Interferential Current Therapy
Public Device Record Key
530d4d17-074e-4ce4-a3c0-1d0dcc504deb
Public Version Date
August 07, 2019
Public Version Number
8
DI Record Publish Date
August 07, 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. | 14 |