Duns Number:080392779
Device Description: The Profile Smart Body Scale measures weight and uses bioelectrical impedance analysis (BI The Profile Smart Body Scale measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
Catalog Number
-
Brand Name
Profile by Sanford
Version/Model Number
LS206-E
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"
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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
K123781,K123781
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
6953e457-8d21-455c-bef0-0b13c910dadc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 31, 2017
Package DI Number
10811392021026
Quantity per Package
4
Contains DI Package
00811392021029
Package Discontinue Date
August 31, 2023
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |