Identifiers
- 510(k) Number
- K201168 FDA 510(k)
- FDA Product Code
- QDA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2345 FDA 510(k)
- Regulation Number
- 870.2345 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ECG Monitor App is a software-only mobile medical device classified as an electrocardiograph for over-the-counter use. It is designed to capture and display single-lead electrocardiogram (ECG) tracings via compatible Samsung Galaxy smartwatches and smartphones, enabling basic cardiac rhythm assessment.
The app operates on supported Samsung Galaxy devices and is intended for single-use per session, with no sterility requirements. It is authorized under FDA 510(k) clearance and EU MDR compliance, with no MRI safety considerations. Availability may vary by region, and users must adhere to age and regional restrictions as specified in the device documentation.
Frequently asked questions
What types of Samsung devices are compatible with the ECG Monitor App for capturing ECG tracings?
The ECG Monitor App is designed specifically for use with compatible Samsung Galaxy smartwatches and smartphones. Availability depends on the device model and region, so users should check the app’s documentation or Samsung’s official support resources to confirm compatibility before installation.
Is the ECG Monitor App intended for repeated use over multiple sessions, or is it meant for single-use?
The app is intended for single-use per session, meaning it is not designed to be reused across multiple ECG recordings. Each session requires a fresh use of the app, though the underlying device (smartphone/watch) may be reused for subsequent sessions.
Does the ECG Monitor App require sterilization before or after use, and how should it be handled?
Since the ECG Monitor App is a software-only mobile medical device and operates on consumer-grade devices (smartphones/watches), there are no sterility requirements. However, standard hygiene practices—such as handwashing before handling the device—are recommended to maintain cleanliness.
What kind of cardiac information can the ECG Monitor App provide, and what limitations should users be aware of?
The app captures and displays single-lead ECG tracings, enabling basic assessment of cardiac rhythm. However, it is not intended for comprehensive diagnostic purposes. Users should consult a healthcare professional for any abnormal findings, as the app lacks advanced diagnostic capabilities like multi-lead analysis or clinical interpretation.
How do I determine if the ECG Monitor App is legally available for use in my region?
Availability varies by region due to regulatory restrictions. The app holds FDA 510(k) clearance and EU MDR compliance, but users must verify local laws and age restrictions in their country. Always refer to the app’s documentation or Samsung’s regional support for confirmation before downloading or using it.
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: Samsung Health Monitor, Samsung Health Monitor, Samsung Health Monitor APK for Android Download - APKPure.com, Samsung Health Monitor | Apps & Services | Samsung US
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 | K201168 | Class II | Active |
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Manufacturer
- Manufacturer
- Samsung Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K201168 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026