# K163694: Rooti Rx ECG Event Recorder, Rooti Link APP Software

- Pathway: 510(k) (Traditional)
- Applicant: Rooti Labs, Ltd.
- Decided: Nov 7, 2017 after 314 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K123658 (2013). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123658: Biomodule 3-M1, Zephyr Technology Corporation (2013) Summary page 4.

## Most influential descendants
- K213233: EZYPRO ECG Recorder (Model: UG02) (2022), 0 descendants of its own

## Indications for use
- The intended use of the Rooti Rx System is to allow a patient at home or in the workplace to record single-lead electrocardiography (ECG) data for post-analysis by medical professionals. The Rooti Rx device stores the ECG data, and the recorded data is transmitted to a medical professional’s iOS device via Wi-Fi at a later time. - The device is not intended to be used on critical care patients. The Rooti Rx System is indicated for use on general care patients and on patients who are 21 years of age or older.

Source page: https://510kreport.com/device/K163694
Methodology: https://510kreport.com/methodology