FDA 510(k) · LifeSignals
K200690: LifeSignals ECG Remote Monitoring Patch Platform (Lifesignals, Inc.)
Lifesignals, Inc. received FDA 510(k) K200690 for LifeSignals ECG Remote Monitoring Patch Platform, with a decision date of Jul 15, 2020 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K200690 |
|---|---|
| Pathway | 510(k) |
| Applicant | Lifesignals, Inc. |
| Device name | LifeSignals ECG Remote Monitoring Patch Platform |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Mar 16, 2020 |
| Decision date | Jul 15, 2020 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The LifeSignals ECG Remote Monitoring Patch Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and Heart Rate monitoring in home and healthcare settings. Data is transmitted wirelessly from LifeSignals Biosensor Patch to Remote secure server for storage and analysis. The LifeSignals ECG Remote Monitoring Patch Platform is intended for non-critical, adult population, who are 18 years of age or older. The LifeSignals ECG Remote Monitoring Patch Platform includes an ability to notify healthcare professionals when Heart Rate falls outside the set limits. 5.9 Substantial Equivalence comparison (Subject device &
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
Later records that cite K200690
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DRG is "Transmitters And Receivers, Physiological Signal, Radiofrequency", class 2, 21 CFR 870.2910.
Our labels for filtering: claim Remote / vital-sign monitoring, sensor ECG electrodes. These are heuristics, not FDA fields.