Duns Number:560082555
Catalog Number
-
Brand Name
Belifu
Version/Model Number
FM-B2403
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)
-
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
e5d420c8-1f1b-4726-811f-6b557c79d2d0
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
November 03, 2020
Package DI Number
16973810850039
Quantity per Package
45
Contains DI Package
06973810850032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |