Duns Number:066689993
Device Description: BODYMED DIGITAL EMS DUAL CHANNEL UNIT INCLUDES 2 LEAD WIRES, 1 PACK OF 4-1 3/4" ROUND CLO BODYMED DIGITAL EMS DUAL CHANNEL UNIT INCLUDES 2 LEAD WIRES, 1 PACK OF 4-1 3/4" ROUND CLOTH ELECTRODES, 9 VOLT BATTERY, CARRYING CASE, MANUAL
Catalog Number
ZZAEV805
Brand Name
BodyMed
Version/Model Number
ZZAEV805
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
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
0fc1c1e9-c7d0-4652-8ae4-636841f2d016
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 05, 2016
Package DI Number
20815802014520
Quantity per Package
32
Contains DI Package
10815802014523
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 |