# K061993: Equivital, Model EQ-01

- Pathway: 510(k) (Traditional)
- Applicant: Hidalgo Limited
- Decided: Nov 3, 2006 after 112 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K962603 (1997). 22 ancestors in all.
99 later devices descend from it; 3 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030795: Lifesyne Systems, Gmp/Companies, Inc. (2003) Summary page 2.
- K040605: Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb Movement Sensor, Model 3100, Dymedix, Inc. (2004) Summary page 2.
- K003520: Nexan System, Model NX-300, Nexan, Ltd. (2000) Summary page 2.
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246, Welch Allyn Protocol, Inc. (2001) Summary page 2.
- K052489: Actiheart, Respironics, Inc. (2005) Summary page 2.
- K043604: Lifeshirt Real-Time with Vivomonitor Software, Vivometrics, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch (2015), 43 descendants of its own
- K081140: Visensia (2008), 22 descendants of its own
- K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (2019), 18 descendants of its own

## Indications for use
The Equivital TM Vital Signs Physiological Monitor is an ambulatory multiparameter vital signs telemetry device intended for monitoring of adults (16 - 65years) in hospital care facilities, the home, workplace and alternate care settings. The device consists of a chest belt harness and a body worn electronics module (SEM) supported by the chest belt. The device collects and transmits ECG data and rate, respiration data and rate, skin temperature, body orientation and motion. The monitor is indicated for use as a general patient monitor, to provide physiological information as part of an occupational welfare monitoring system, and for general research and performance measurement purposes.

Source page: https://510kreport.com/device/K061993
Methodology: https://510kreport.com/methodology