Fitbit Irregular Rhythm Notifications
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Fitbit LLC
Identifiers
- 510(k) Number
- K212372 FDA 510(k)
- FDA Product Code
- QDB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2790 FDA 510(k)
- Regulation Number
- 870.2790 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Photoplethysmograph Analysis Software for Over-the-Counter Use, designed to analyze heart rate data from compatible wrist-worn devices. It identifies potential irregular heart rhythms, including those suggestive of atrial fibrillation (AFib), and provides notifications to users based on detected anomalies.
The software operates as a mobile medical application, requiring pairing with compatible Fitbit wrist-worn devices to collect and process pulse rate data. Supplied as a downloadable application, it is classified as a Class II (Moderate Risk) device under FDA regulations (Product Code: QDB) and has received FDA 510(k) clearance and MDR authorization. No physical sterility or single-use requirements apply, as it is a software-only solution.
Frequently asked questions
How does the Fitbit Irregular Rhythm Notifications software work, and what kind of heart rhythm issues does it detect?
The Fitbit Irregular Rhythm Notifications software analyzes heart rate data collected from compatible Fitbit wrist-worn devices using photoplethysmography (PPG) technology. It specifically identifies potential irregular heart rhythms, including patterns suggestive of atrial fibrillation (AFib), by detecting anomalies in the user’s pulse data. The app then provides notifications to alert users when these irregularities are detected.
Is this software available as a standalone product, or does it require pairing with a specific device?
This software is not a physical device but a mobile medical application that must be downloaded and installed on a compatible smartphone. It requires pairing with a compatible Fitbit wrist-worn device to collect and process pulse rate data for irregular rhythm analysis. The software itself is supplied as a downloadable app, not as a standalone hardware unit.
What regulatory approvals does the Fitbit Irregular Rhythm Notifications software have, and how does it classify under medical device regulations?
The Fitbit Irregular Rhythm Notifications software has received FDA 510(k) clearance and MDR authorization, classifying it as a Class II (Moderate Risk) device under FDA regulations. It falls under Product Code QDB and is intended for over-the-counter use, meaning it is designed for consumer access without requiring a prescription or clinical supervision.
Since this is a software-only solution, does it have any sterility or single-use requirements?
No, the Fitbit Irregular Rhythm Notifications software does not have sterility or single-use requirements because it is entirely digital and does not involve physical components that could require sterilization. It is designed for repeated use on compatible devices and smartphones, with no expiration or disposal constraints beyond standard software updates and device compatibility.
Are there different versions or models of this software, or is it a single unified application?
The Fitbit Irregular Rhythm Notifications software appears to be a single unified application available for download, though it may be compatible with multiple generations or models of Fitbit wrist-worn devices. The specifications do not indicate separate versions or models of the software itself, only that it relies on data from compatible Fitbit hardware for functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fitbit Irregular Rhythm Notifications User Guide - Manuals+, Fitbit Irregular Rhythm Notifications: Instructions for Use, Fitbit Irregular Rhythm Notifications — FDA Class II Medical Device ..., AccessGUDID - DEVICE: Fitbit Irregular Rhythm Notifications ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212372 | Class II | Active |
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Manufacturer
- Manufacturer
- Fitbit LLC
- FDA Applicant
- Fitbit, Inc.
Sources (2)
- FDA 510(k) K212372 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026