QDA · Electrocardiograph Software For Over-The-Counter Use
Cardiovascular · 21 CFR 870.2345 · Class 2
Overview
| Product Code | QDA |
|---|---|
| Device Name | Electrocardiograph Software For Over-The-Counter Use |
| Regulation | 21 CFR 870.2345 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In combination with the general controls of the FD&C Act, the electrocardiograph software for over-the-counter use is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Clinical performance testing under anticipated conditions of use must demonstrate the following: (i) The ability to obtain an electrocardiograph of sufficient quality for display and analysis; and (ii) The performance characteristics of the detection algorithm as reported by sensitivity and either specificity or positive predictive value. (2) Software verification, validation, and hazard analysis must be performed. Documentation must include a characterization of the technical specifications of the software, including the detection algorithm and its inputs and outputs. (3) Non-clinical performance testing must validate detection algorithm performance using a previously adjudicated data set. (4) Human factors and usability testing must demonstrate the following: (i) The user can correctly use the device based solely on reading the device labeling; and (ii) The user can correctly interpret the device output and understand when to seek medical care. (5) Labeling must include: (i) Hardware platform and operating system requirements; (ii) Situations in which the device may not operate at an expected performance level; (iii) A summary of the clinical performance testing conducted with the device; (iv) A description of what the device measures and outputs to the user; and (v) Guidance on interpretation of any results.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240795 | Withings ECG App | Withings | Jun 15, 2025 | SESE |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) | Whoop., Inc. | Apr 4, 2025 | SESE |
| K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | Aug 2, 2024 | SESE |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | May 2, 2023 | SESE |
| K221774 | Garmin ECG App | Garmin International, Inc. | Jan 12, 2023 | SESE |
| K201525 | ECG App | Apple, Inc. | Oct 8, 2020 | SESE |
| K200948 | Fitbit ECG App | Fitbit, Inc. | Sep 11, 2020 | SESE |
| K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | Aug 4, 2020 | SESE |
| DEN180044 | ECG App | Apple, Inc. | Sep 11, 2018 | DENG |
Top Applicants
- Samsung Electronics Co., Ltd. — 3 clearances
- Apple, Inc. — 2 clearances
- Fitbit, Inc. — 1 clearance
- Garmin International, Inc. — 1 clearance
- Whoop., Inc. — 1 clearance
