Duns Number:066512101
Device Description: A patented ultra-thin design equipped with advanced EMS program. Electrical stimulation ac A patented ultra-thin design equipped with advanced EMS program. Electrical stimulation activates muscle self-exercising. Wireless & Portable. 15 Intensity Levels. one-piece structure EMS device. Exercise with 3 cycles for 20 minutes. Adjustable Stimulation Intensity. Muscle recovery & performance tool.
Catalog Number
8082
Brand Name
Addaday
Version/Model Number
EMS Type B
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
Yes
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
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
5b77bd75-aed8-4cb7-88cd-694aaf7e18d9
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
March 07, 2019
Package DI Number
10860001326816
Quantity per Package
40
Contains DI Package
00860001326819
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |