Duns Number:658608864
Device Description: ● Well-Life Digital TENS/EMS stimulator, prescription device .● Intended for symptomatic r ● Well-Life Digital TENS/EMS stimulator, prescription device .● Intended for symptomatic relief of chronic intractable pain (TENS), and EMS intended for: Relax muscle spasms/ Prevent or retard disuse atrophy/ Increase local blood circulation/ Re-educate muscles/ Maintain or increase the range of motion
Catalog Number
-
Brand Name
WELL-LIFE
Version/Model Number
WL-2205
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
K033857
Product Code
LIH
Product Code Name
Interferential Current Therapy
Public Device Record Key
6c19266f-6e51-4846-a1f4-9ef95cadbfb5
Public Version Date
May 23, 2019
Public Version Number
5
DI Record Publish Date
April 26, 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 |