Duns Number:829454672
Device Description: The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to mea The ARIA WiFi Smart Scale uses the Bioelectrical Impedance Analysis (BIA) technique to measure body fat composition by sending a low, safe electrical current throughout the body (“foot-to-foot”). The current passes through muscle tissue with lower resistance than through fat tissue. The resistance in fat tissue is termed “bioelectrical impedance” and is the principle of operation for the ARIA scale measurement. The ARIA scale displays the measurement results to the user on a large display that is backlit and easy to read from the standing position. Measurement results include body weight (lb, kg, stone) and body fat (percentage). The scale stores up to 16 readings. The scale is battery operated (4-AA batteries). Prior to use, the user creates a confidential profile on the Fitbit website (which is only available to the user unless affirmatively shared by the user with other users). The scale has an added functionality of wirelessly transmitting the readings to the user’s profile for trending. The user profile is stored locally on the scale, so that the functionality of the scale is autonomous after initial setup.Up to eight (8) users may create profiles to use a single scale. The scale has an automatic recognition function, where it recognizes the user based on the user’s previous weight and profile. If two users have similar body weight profiles, they will be prompted to identify themselves using their initials at the time of weight measurement (selection by tapping the appropriate side of the scale).The complementary interface with the Fitbit website allows the user to view their body weight and body fat trend data over time.
Catalog Number
FB201B
Brand Name
Aria
Version/Model Number
FB201B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2018
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)
Yes
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133872
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
52441c10-e03f-47bc-8e2f-52602500c60c
Public Version Date
October 31, 2018
Public Version Number
5
DI Record Publish Date
October 21, 2016
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. | 7 |