# K043604: Lifeshirt Real-Time with Vivomonitor Software

- Pathway: 510(k) (Traditional)
- Applicant: Vivometrics, Inc.
- Decided: Apr 29, 2005 after 121 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
155 later devices descend from it; 5 cite it directly.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Reusable Multiple-Patient LifeShirt with VivoLogic Analysis Software: named in the summary without a submission number
- (no number) GMP Companies, Inc., LifeSync® Wireless ECG System: named in the summary without a submission number
- (no number) Life Sensing Instrument Company, Teletrens Model TM1O Multi-Parameter Portable Patient Transmitter: named in the summary without a submission number
- (no number) Mortara Instrument Inc., Ambulatory X-12 Telemetry Module: named in the summary without a submission number

## Most influential descendants
- K061993: Equivital, Model EQ-01 (2006), 99 descendants of its own
- K113054: Equivital (2012), 71 descendants of its own
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library) (2014), 70 descendants of its own
- K083287: Avivo Mobile Patient Management System (2009), 57 descendants of its own
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch (2015), 43 descendants of its own

## Indications for use
The LifeShirt Real-Time is intended for use during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, temperature, and body position data may be collected. The system is interfded to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. The LifeShirt Real-Time is indicated for reuse by multiple adult patients in applications that may include pharmaceutical studies in which respiratory information is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.

Source page: https://510kreport.com/device/K043604
Methodology: https://510kreport.com/methodology