ASSURE Wearable ECG is an AI-enabled medical device from Kestra Medical Technologies, Inc. that the U.S. FDA cleared through 510(k) K233864 on May 7, 2024. Its lead review panel is Cardiovascular and its primary product code is MWJ (Electrocardiograph, Ambulatory (Without Analysis)).
See also FDA-cleared AI cardiovascular devices in 2024, all FDA AI clearances in 2024, top cardiovascular AI devices.
Key facts
| Submission number | K233864 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Kestra Medical Technologies, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | MWJ — Electrocardiograph, Ambulatory (Without Analysis) |
| Applicant (openFDA) | Kestra Medical Technologies, Inc. |
| Applicant location | Kirkland, WA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2800 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. ASSURE Wearable ECG went through this pathway (K233864).
openFDA lists it as a Class 2 device under 21 CFR 870.2800. Class II devices are moderate risk and are subject to general and special controls.
Product code MWJ covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Kestra Medical Technologies, Inc. has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.