# K031550: Reusable Multiple-Patient Lifeshirt with Vivologic Analysis Software

- Pathway: 510(k) (Traditional)
- Applicant: Vivometrics, Inc.
- Decided: Jul 29, 2003 after 74 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Lifeshirt with VivoLogic Analysis Software (Reusable Single-Patient Lifeshirt): named in the summary without a submission number

## Indications for use
The Reusable Multiple-Patient Lifeshirt 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, and body position data may be collected. The system is intended 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 Reusable Multiple-Patient Lifeshirt 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 this data provided to their physicians as an aid to diagnosis and treatment.

Source page: https://510kreport.com/device/K031550
Methodology: https://510kreport.com/methodology