# K191331: Life Sensor Cardiac Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Braveheart Wireless, Inc.
- Decided: Jun 12, 2019 after 27 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: 13 generations back to K962603 (1997). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172011: LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System), Hmicro, Inc. (2018) Summary page 4.

## Indications for use
The Life Sensor Cardiac Monitor (CM) is a wireless monitoring system intended for use by healthcare professionals for monitoring of physiological data within healthcare settings. This includes heart rate and electrocardiography (ECG). Data is transmitted wirelessly from Life Sensor Electrode to an application on iOS device where it is displayed for review by healthcare professionals. The device is intended for use on general care patients 18 years or older and by prescription only. The device is contraindicated for use on critical care patients, patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD), and left ventricular assist devices (LVAD); for use in magnetic resonance (MR) environments; for use during surgical procedures when electro-surgical equipment is optional. The Life Sensor Cardiac Monitor does not detect or diagnose medical conditions.

Source page: https://510kreport.com/device/K191331
Methodology: https://510kreport.com/methodology