BodyGuardian Remote Monitoring System is an AI-enabled medical device from Preventice Technologies, Inc. that the U.S. FDA cleared through 510(k) K192732 on March 26, 2020. Its lead review panel is Cardiovascular and its primary product code is DSI (Detector And Alarm, Arrhythmia).
See also FDA-cleared AI cardiovascular devices in 2020, all FDA AI clearances in 2020, top cardiovascular AI devices.
Key facts
| Submission number | K192732 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Preventice Technologies, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | DSI — Detector And Alarm, Arrhythmia |
| Applicant (openFDA) | Preventice Technologies, Inc. |
| Applicant location | Rochester, MN, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.1025 |
| 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. BodyGuardian Remote Monitoring System went through this pathway (K192732).
openFDA lists it as a Class 2 device under 21 CFR 870.1025. Class II devices are moderate risk and are subject to general and special controls.
Product code DSI covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Preventice 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.