Duns Number:066689993
Device Description: Fully digital BodyMed TENS unit, ZZAEV810, 10 programs, includes a carrying case, an adapt Fully digital BodyMed TENS unit, ZZAEV810, 10 programs, includes a carrying case, an adapter and two 9 V batteries
Catalog Number
ZZAEV810
Brand Name
BodyMed
Version/Model Number
ZZAEV810
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
63af98f6-b4eb-401d-a2a3-bff5ce14dada
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 12, 2016
Package DI Number
10815991020367
Quantity per Package
1
Contains DI Package
00815991020377
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carrying Case
| 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 |