Duns Number:079578783
Catalog Number
-
Brand Name
Etekcity Smart Fitness Scale
Version/Model Number
EFS-A591S-WUST
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
5c5c590d-f32c-47ce-a114-0aa2ff657037
Public Version Date
September 01, 2021
Public Version Number
1
DI Record Publish Date
August 24, 2021
Package DI Number
10817915028213
Quantity per Package
5
Contains DI Package
00817915028216
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 |