Rooti Rx ECG Event Recorder, Rooti Link APP Software is an AI-enabled medical device from Rooti Labs Ltd. that the U.S. FDA cleared through 510(k) K163694 on November 7, 2017. Its lead review panel is Cardiovascular and its primary product code is DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency).
See also FDA-cleared AI cardiovascular devices in 2017, all FDA AI clearances in 2017, top cardiovascular AI devices.
Key facts
| Submission number | K163694 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Rooti Labs Ltd. |
| Lead review panel | Cardiovascular |
| Primary product code | DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant (openFDA) | Rooti Labs , Ltd. |
| Applicant location | Taipei, TW |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2910 |
| 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. Rooti Rx ECG Event Recorder, Rooti Link APP Software went through this pathway (K163694).
openFDA lists it as a Class 2 device under 21 CFR 870.2910. Class II devices are moderate risk and are subject to general and special controls.
Product code DRG covers 3 devices on the FDA AI list. By decision date, this device is #1 of 3 under that code. Rooti Labs Ltd. 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.