Zensor

The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable…

Registry build 21.09.26

The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body. The device is to be used in the patient’s home environment to provide clinicians with patient physiological data, while allowing for patient mobility. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The physiological parameters monitored include ECG and Respiration waveforms, Heart Rate and Respiration Rate, as well as lethal and high acuity arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation). The zensor monitoring device has the option to store full disclosure ECG & Respiration data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory ECG Full Disclosure ECG and Event Viewer) for later analysis by a clinician.

9manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code

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.

Chinese manufacturers registered for FDA product code MHX
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

Regulatory record for Zensor
Listed by Intelesens 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
510(k) K151027
Record published 2019-01-07
Record revised 2018-07-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Zensor
Catalogue number Size Status
PN1287 In distribution
PN0620 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
Clearance Decision date
K153275 2016-02-26
K151027 2015-10-02
K110015 2011-05-20

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer