# K172011: LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)

- Pathway: 510(k) (Traditional)
- Applicant: Hmicro, Inc.
- Decided: Jun 14, 2018 after 346 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: 12 generations back to K962603 (1997). 61 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150992: Vios Monitoring System, Vios Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K191331: Life Sensor Cardiac Monitor (2019), 0 descendants of its own

## Indications for use
The LifeSignals WiPatch & WiApp system is intended for spot check and short-term monitoring of ECG & heart rate of patients at rest or patients who can be transported within the range of the antenna network. The WiPatch & WiApp system has visual and audio alarms to alert clinical personnel when heart rate falls outside the set limits. The device is intended for use on general care patients of 18 years or older. The device is not intended for use on critical care patients. The LifeSignals WiPatch & WiApp System is contraindicated for use on patients with active implantable medical devices such as pacemakers, implanted cardioverter defibrillator (ICD) & left ventricular assist devices (LVAD); for use in a magnetic resonance (MR) environment; for use during surgical procedures when electro-surgical equipment is operational.

Source page: https://510kreport.com/device/K172011
Methodology: https://510kreport.com/methodology