FDA 510(k) · Fitbit
K200948: Fitbit ECG App (Fitbit, Inc.)
Fitbit, Inc. received FDA 510(k) K200948 for Fitbit ECG App, with a decision date of Sep 11, 2020 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K200948 |
|---|---|
| Pathway | 510(k) |
| Applicant | Fitbit, Inc. |
| Device name | Fitbit ECG App |
| Product code | QDA: Electrocardiograph Software For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2345 |
| Device class | Class 2 |
| Date received | Apr 8, 2020 |
| Decision date | Sep 11, 2020 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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 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 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.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- DEN180044 ECG App (Apple)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QDA is "Electrocardiograph Software For Over-The-Counter Use", class 2, 21 CFR 870.2345. FDA's definition: "An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis."
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.