Duns Number:658608864
Device Description: ● It is intended for temporary relief of pain associated with sore and aching muscles in t ● It is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.● OTC TENS, Patch type.
Catalog Number
-
Brand Name
WELL-LIFE
Version/Model Number
WL-2406
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 25, 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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133723
Product Code
LIH
Product Code Name
Interferential Current Therapy
Public Device Record Key
84b54180-8d0e-49f0-a6e9-0ca1fa9889ce
Public Version Date
May 23, 2019
Public Version Number
5
DI Record Publish Date
April 25, 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 |