Duns Number:160641309
Device Description: Transcutaneous Electrical Nerve Stimulator for Pain. The WellnessPro 2010 Plus is designed Transcutaneous Electrical Nerve Stimulator for Pain. The WellnessPro 2010 Plus is designed to provide electrical stimulation, for relief of chronic, intractable pain and as an adjunctive treatment of post-surgical or port-traumatic acute pain, in a single compact, lightweight user friendly package.
Catalog Number
-
Brand Name
WELLNESSPRO
Version/Model Number
2010 PLUS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 23, 2018
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K062616
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
2b407420-2105-43f5-807a-6d03a6f10a2d
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
July 21, 2016
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. | 9 |