Duns Number:008965063
Device Description: 1 Tens control unit with 1 pc of 53 mm x 73 mm pad, 1pc of 190 mm X 95 mm pad & battery .
Catalog Number
-
Brand Name
Well at Walgreens
Version/Model Number
FDES105B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130723,K130723,K130723
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
34a5ac25-8cd4-4b5c-bcbf-82a67f84e73a
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
August 16, 2016
Package DI Number
10311917176380
Quantity per Package
12
Contains DI Package
00311917176383
Package Discontinue Date
October 19, 2016
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |