Duns Number:014593382
Catalog Number
-
Brand Name
HealthmateForever
Version/Model Number
Accessories - 2.5mm 2in1 Pin Wire Connector
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
NGX
Product Code Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Public Device Record Key
e8fe9b56-defd-4a12-9526-a9663ab63d21
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
April 25, 2018
Package DI Number
10817856020604
Quantity per Package
1000
Contains DI Package
00817856020607
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |