Duns Number:079578783
Catalog Number
-
Brand Name
Etekcity Smart Fitness Scale
Version/Model Number
FIT 8S
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
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
583f672b-d351-4ee2-902b-29b7a7645eba
Public Version Date
December 30, 2019
Public Version Number
1
DI Record Publish Date
December 20, 2019
Package DI Number
10817915020071
Quantity per Package
8
Contains DI Package
00817915020074
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |