Wearable Biosensor - ECG Remote Monitoring Biosensor Patch

Wearable Biosensor
LifeSignals - LP1253

An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be wirelessly transmitted and analysed, typically to a remote computer with a dedicated software located at a medical facility. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DRG

Device Name: Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2910

Third Party Flag: Y

Medical Specialty: CV

Code: MWJ

Device Name: Electrocardiograph, Ambulatory (Without Analysis)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2800

Third Party Flag: N

Medical Specialty: CV

Code: QYX

Device Name: Outpatient Cardiac Telemetry

Device Class: 2

Physical State: Battery-operated, Portable or body worn, Wet and/or dry electrodes, Wireless transmissions

Definition: Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of electrocardiograms acquired. Not for use for detection or notification of hemodynamically unstable or life-threatening arrhythmias or cardiac events requiring urgent medical response. Not intended for patients at elevated risk of serious cardiovascular events that would require prompt intervention. It is not intended for monitoring patients during cardiac rehabilitation outside of healthcare facilities. Devices are intended for prescription use only.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Records electrocardiogram through electrodes on a portable or body worn device and allow remote display of the electrocardiogram. Continuously and automatically analyzes the ECG and provides notifications during the monitoring period.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Body

Regulation Number: 870.1025

Third Party Flag: N

Medical Specialty: CV

Device Id: B353LP12532

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B353LP12531

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Small Box

Device Id: B353LP12531

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: B353LP12533

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B353LP12532

Package Quantity: 8

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Big Box