LifeShirt System with VivoLogic Analysis Software
by Vivometrics, Inc. 510(k)
Active
510(k) K011903
Overview
The LifeShirt System with VivoLogic Analysis Software is a wearable, non-invasive monitoring device classified as a cardiopulmonary diagnostic system (FDA Product Code: DQK). It combines inductive plethysmography and ECG sensors integrated into a vest to continuously measure respiratory effort, heart rate, and other physiological parameters. Designed for ambulatory use, it provides real-time data collection and analysis to support the assessment of sleep-disordered breathing and related conditions. The system’s software processes and interprets the recorded signals for clinical evaluation.
The device is supplied as a reusable, multi-patient system comprising a LifeShirt vest with embedded sensors, a battery-powered Handspring Visor for data collection, and PC-based VivoLogic 1.0 analysis software. It operates in both home and clinical settings, with data transfer enabled via CompactFlash memory cards or direct PC connectivity. The system is not sterile and requires proper storage to maintain sensor integrity. FDA clearance (510(k) K011903) confirms its substantial equivalence to a predicate device under the Cardiovascular advisory committee’s review
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011903 | Date12 Apr 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DQK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vivometrics, Inc.
Questions
What types of physiological parameters does the LifeShirt System measure, and how is this data collected?
The LifeShirt System measures respiratory effort, heart rate, and other cardiopulmonary parameters through a wearable vest with embedded inductive plethysmography and ECG sensors. The data is collected in real-time during ambulatory use, meaning it can be monitored continuously while the patient moves freely in both home and clinical settings.
Is the LifeShirt System designed for single-use or reusable applications, and how should it be stored?
The LifeShirt System is a reusable, multi-patient device. Since it is not sterile, proper storage is required to maintain sensor integrity and functionality. The manufacturer recommends following guidelines to preserve the vest and components for repeated use.
How does the LifeShirt System transfer data for analysis, and what software is included for interpreting the results?
Data from the LifeShirt System is transferred via CompactFlash memory cards or direct PC connectivity. The system includes VivoLogic 1.0 analysis software, which processes and interprets the recorded signals to support clinical evaluation of sleep-disordered breathing and related conditions.
What settings can the LifeShirt System be used in, and what is its intended purpose based on FDA clearance?
The LifeShirt System is designed for use in both home and clinical settings. Its FDA clearance (510(k) K011903) confirms it is classified as a cardiopulmonary diagnostic system, intended for assessing sleep-disordered breathing and related conditions through continuous, non-invasive monitoring.