FDA 510(k) · LifeSignals
K202868: LifeSignals Multi-Parameter Remote Monitoring Platform (Lifesignals, Inc.)
Lifesignals, Inc. received FDA 510(k) K202868 for LifeSignals Multi-Parameter Remote Monitoring Platform, with a decision date of Jul 21, 2021 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K202868 |
|---|---|
| Pathway | 510(k) |
| Applicant | Lifesignals, Inc. |
| Device name | LifeSignals Multi-Parameter Remote Monitoring Platform |
| Product code | DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation (21 CFR) | 870.2910 |
| Device class | Class 2 |
| Date received | Sep 28, 2020 |
| Decision date | Jul 21, 2021 |
| 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 Multi-parameter Remote Monitoring Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data at home and in healthcare settings. This shall include Electrocardiography (2-channel ECG), Heart Rate, Respiration Rate, Skin Temperature & Posture. Data is transmitted wirelessly from LifeSignals Biosensor to Remote secure server for display, storage & analysis. • The LifeSignals Multi-Parameter Remote Monitoring Platform is intended for non- critical, adult population. • The LifeSignals Multi-Parameter Remote Monitoring Platform can include the ability to notify healthcare professionals when Physiological parameters fall outside the set limits and to display multiple patient physiological data for remote monitoring.
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 K202868
- K242018 UbiqVue 2A Multi-parameter System (UX2550) (LifeSignals, Nov 12, 2024, DRG)
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 Unknown. These are heuristics, not FDA fields.