Cardiovascular · 510(k) · 2017
Rooti Rx ECG Event Recorder, Rooti Link APP Software
Rooti Labs Ltd.. Cleared by FDA on 7 November 2017 under submission K163694, product code DRG (transmitters and receivers, physiological signal, radiofrequency). What FDA's record says, in FDA's words.
Device record · K163694
- Device. Rooti Rx ECG Event Recorder, Rooti Link APP SoftwareDEVICE
- Company. Rooti Labs Ltd. (TW)COMPANY
- Decision. 7 November 2017, 510(k), substantially equivalent (traditional review); received 28 December 2016DECISION
- Panel. CardiovascularPANEL
- Product code. DRG, Transmitters And Receivers, Physiological Signal, RadiofrequencyCODE
- Regulation. 21 CFR 870.2910, Class IIREG
- Source. FDA database entry · decision document (8 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 1,732 reports filed against devices carrying product code DRG. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
17 September 2026 · Malfunction · ORG-9110A · Nihon Kohden Corporation · report 8030229-2026-07149
16 September 2026 · Malfunction · ORG-9110A · Nihon Kohden Corporation · report 8030229-2026-07147
The Biomedical Engineer (Biomed) reported that at the Central Nurse's Station (CNS), the ZM tele was swapping between 3 different patient's names. Those were the last 3 patients admitted on this tele before the current patient was admitted. No patient harm was reported.
9 September 2026 · Malfunction · Surveyor S4 · BAXTER HEALTHCARE CORPORATION · report 3006087789-2026-00021
4 September 2026 · Malfunction · ORG-9110A · Nihon Kohden Corporation · report 8030229-2026-07105
2 September 2026 · Malfunction · ORG-9110A · Nihon Kohden Corporation · report 8030229-2026-07098
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DRG, in Cardiovascular, or cleared in 2017. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.