Duns Number:544587118
Device Description: The EMS stimulation program stimulates healthy muscles in order to improve and facilitate The EMS stimulation program stimulates healthy muscles in order to improve and facilitate muscle performance.
Catalog Number
-
Brand Name
ROOVJOY
Version/Model Number
R-E1
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
K180956,K180956
Product Code
NGX
Product Code Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Public Device Record Key
21396e11-d036-45f1-886f-b11195acc8a7
Public Version Date
August 19, 2022
Public Version Number
7
DI Record Publish Date
July 16, 2018
Package DI Number
10840001700038
Quantity per Package
50
Contains DI Package
00840001700031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |