RevMed

FITBIT, INC. FB603 Fitbit ECG App

Company Name
FITBIT, INC.
Catalog Number
FB603

Description

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 AF detection function 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 ECG Spot Check isintended for informational use only. The user is not intended to 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 is 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
Have questions or need more information? Contact Us
RevMed is an independent marketplace for reselling medical devices and equipment. We are not affiliated with or endorsed by manufacturers, and all trademarks and brand names belong to their respective owners. Product images and descriptions are for reference only, and RevMed does not provide medical advice, training, or support.
Find Savings Automatically!
Your trusted browsing companion

Additional Details

Device Identifier
00810038851983
Is RX
No
Is Over the Counter
Yes
Requires Sterilization
No
Is Sterile
No
Is Single Use
No

Barcode Mapping

Unit of MeasurementEachesGTIN
Each100810038851983