Duns Number:658608864
Device Description: Digital buttons controlled stimulator, with multiple modalities, optional 2 or 4 channels. Digital buttons controlled stimulator, with multiple modalities, optional 2 or 4 channels. This Device is only for prescription use.
Catalog Number
-
Brand Name
WELL-LIFE
Version/Model Number
WL-2504
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 29, 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
K100399
Product Code
LIH
Product Code Name
Interferential Current Therapy
Public Device Record Key
1483195a-7d6c-43e9-998f-504d9324eef9
Public Version Date
May 23, 2019
Public Version Number
5
DI Record Publish Date
March 29, 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 |