The ARIA WiFi Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 10 years of age or older. It is intended for home use only.
Features:
The device has a “foot-to-foot” bioelectrical impedance analysis technique and uses a WiFi module to connect to the internet and transmit data to the user’s Fitbit account.
Performance Testing:
The device has been tested according to IEC 60601-1 and IEC 80601-1-2 and was found to meet all requirements. A small comparative clinical study was conducted to compare body fat composition (%) in 25 male and 25 female subjects using the ARIA WiFi Smart Scale vs. the predicate device, and the results showed that the measurements from ARIA were not statistically different from the predicate device (p>0.05) and body fat measurements varied by <8% from one another.
Labeling Requirements:
The device labeling must be truthful and not misleading, and the manufacturer must comply with all requirements of the Act, including but not limited to registration and listing, labeling, medical device reporting, and good manufacturing practice requirements.
Manual:
Download: Summary of Safety and Effectiveness for ARIA WiFi Smart Scale: 510(k) Submission
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