Duns Number:421320739
Catalog Number
-
Brand Name
TAOTRONICS Wireless Body Composition Smart Scale
Version/Model Number
TT-FS001
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
K112149
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
d9304bcb-9938-4c2e-b78f-c1bc85dfe8ee
Public Version Date
March 08, 2021
Public Version Number
5
DI Record Publish Date
December 04, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |