Home Trak Plus EASI Event Recorder System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Paceart Home Trak Plus Easi Event Recorder System

510(k) Number

K982090 ↗

FDA Product Code

DXH

Device Class

Class II

Regulation

21 CFR Part 870.2920

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacemaker Function Analyzer

  Class II

  FDA 510(k) K870909 Active Cleared 27 Apr 1987

• Paceart Cardiovoice

  Class II

  FDA 510(k) K952065 Active Cleared 16 Jan 1996

• Paceart TX3 Cardiac Event Recorder

  Class II

  FDA 510(k) K012407 Active Cleared 14 Aug 2001

• Paceart Cardiophone

  Class II

  FDA 510(k) K931296 Active Cleared 1 Oct 1993

• Paceart Pacemaker Patient Test Syst/Tel Opt Cpts

  Class II

  FDA 510(k) K880283 Active Cleared 9 Mar 1988

• Heart Access Plus Cardiac Event Recorder

  Class II

  FDA 510(k) K973141 Active Cleared 12 Nov 1997

See all devices from Paceart, Inc. →

• What is the Home Trak Plus EASI Event Recorder System used for?

  The Home Trak Plus EASI Event Recorder System is designed to detect and record infrequent or elusive cardiac arrhythmias in patients outside clinical settings. It uses a five-electrode system to generate a 12-lead electrocardiogram (EASI system), allowing for detailed cardiac monitoring. The recorded data is then transmitted via telephone to a central analysis center for review by healthcare professionals, enabling remote monitoring of cardiac events.

• How is the Home Trak Plus EASI Event Recorder System supplied?

  The system consists of two main components: a looping cardiac event recorder worn by the patient and a central-station program for receiving and analyzing the transmitted data. The patient recorder is the primary device used for capturing cardiac events, while the central-station program handles data processing. The manufacturer specifies that the system can be configured for either single-use or reusable applications, though specific handling or sterility instructions are not detailed in the provided data.

• Is the Home Trak Plus EASI Event Recorder System reusable or single-use?

  The Home Trak Plus EASI Event Recorder System can be used in either single-use or reusable configurations, as determined by the manufacturer’s specifications. The decision depends on clinical protocols, facility policies, and cost-effectiveness considerations. Since no explicit sterility requirements or MRI safety information is provided, users should follow manufacturer guidelines to ensure proper handling and reuse if applicable.

• How does the Home Trak Plus EASI Event Recorder System transmit recorded data?

  The system transmits recorded cardiac event data via telephone lines to a central analysis center. This remote transmission capability allows healthcare providers to review the 12-lead ECG recordings without requiring the patient to visit a clinical facility. The central-station program processes and analyzes the transmitted data for further medical evaluation.

• What regulatory pathway was followed for the Home Trak Plus EASI Event Recorder System?

  The Home Trak Plus EASI Event Recorder System was cleared through the FDA’s 510(k) pathway, specifically under the traditional review process. It was submitted to the Cardiovascular (CV) Advisory Committee and classified as substantially equivalent to a predicate device. The clearance number is K982090, and the device falls under the product code DXH for transmitters and receivers used in electrocardiographic purposes.