Duns Number:066689993
Device Description: BODYMED DIGITAL OVER THE COUNTER TENS UNIT
Catalog Number
ZZAEV820OTC
Brand Name
BodyMed
Version/Model Number
ZZAEV820OTC
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
a10c2a12-302f-479a-a78d-f4dc75ce33d0
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 05, 2016
Package DI Number
20815802018825
Quantity per Package
32
Contains DI Package
10815802018828
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |