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510(k) Data Aggregation
K Number
K200948Device Name
Fitbit ECG App
Manufacturer
Fitbit, Inc.
Date Cleared
2020-09-11
(156 days)
Product Code
QDA, ODA
Regulation Number
870.2345Why did this record match?
Applicant Name (Manufacturer) :
Fitbit, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AFib detection feature is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the Fitbit ECG App is intended for informational use only. The user is not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old.
Device Description
The Fitbit ECG App is a software-only medical device used to create, record, display, store and analyze a single channel ECG. The Fitbit ECG App consists of a Device application ("Device app") on a consumer Fitbit wrist-worn product and a mobile application tile ("mobile app") on Fitbit's consumer mobile application. The Device app uses data from electrical sensors on a consumer Fitbit wrist-worn product to create and record an ECG. The algorithm on the Device app analyzes a 30 second recording of the ECG and provides results to the user. Users are able to view their past results as well as a pdf report of the waveform similar to a Lead I ECG on the mobile app.
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K Number
K133872Device Name
ARIA WIFI SMART SCALE
Manufacturer
FITBIT, INC.
Date Cleared
2014-06-02
(164 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
FITBIT, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
ARIA is a body weight scale and a body fat analyzer that operates by using a low, safe, battery-generated electrical current through the body (using a bioelectrical impedance analysis technique) to provide body fat and body weight information. After the user registers their scale, the scale automatically recognizes the subject based on body weight and body fat readings. ARIA contains a WiFi module (802.11 module) that allows it to connect to the Internet in the user's home. The module provides a complementary interface to the Fitbit website. Body weight and body fat measurements are independent of internet communication after initial product registration.
The ARIA scale automatically measures body weight and body fat composition. The scale recognizes the user based on previous weight readings, and can accept up to eight (8) different users. The 16 most recent readings are kept in memory on the scale and readings are also transmitted to the user's optional fitbit.com personal account for trending. If users have similar weight, the proper identity can be selected by tapping the scale.
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