Equivital LifeMonitor
Equivital LifeMonitor EQ02 is a wearable monitor that collects physiological information during daily activity. It is intended for adults aged 16 to 65 in hospital, home, workplace, and…
Equivital LifeMonitor EQ02 is a wearable monitor that collects physiological information during daily activity. It is intended for adults aged 16 to 65 in hospital, home, workplace, and other care settings, including patient monitoring, occupational welfare monitoring, and research.
A chest belt carries skin electrodes and a sensor that measures chest expansion. A connected battery-powered module records and transmits ECG, heart rate, respiratory waveforms and rate, skin temperature, body orientation, and movement to a receiving display.
Data and Alerts
Measurements can be viewed in a PC application or integrated into other monitoring applications. The monitor can provide indications and alerts when physiology crosses predefined boundaries. Wireless configurations include a low-power radio interface or Bluetooth.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | Hidalgo Limited, United Kingdom |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Manufacturer |
| 510(k) | K113054 |
| Record published | 2016-09-24 |
| Record revised | 2025-11-27 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment humidity 0 to 95 % RH; Storage environment temperature -20 to 55 °C |
| Distribution end date | 2023-07-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EQ-EX-SEM-009 | In distribution | |
| EQ-02-B5 | In distribution | |
| EQ-EX-B5 | In distribution | |
| EQ-02-SEM-012 | In distribution | |
| EQ-02-B6 | In distribution | |
| EQ-02-SEM-007 | Withdrawn | |
| EQ-02-B3 | Withdrawn | |
| EQ-02-B2-1 | Withdrawn | |
| EQ-EX-B1-1 | Withdrawn | |
| EQ-02-B1-1 | Withdrawn | |
| EQ-02-B4 | Withdrawn | |
| EQ-EX-B3 | Withdrawn | |
| EQ-EX-B4 | Withdrawn | |
| EQ-EX-SEM-008 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113054 | 2012-02-17 |
| K061993 | 2006-11-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.