← Back to catalogue

Portable ECG Monitor

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K170954

by Contec Medical Systems Co., Ltd.

Identifiers

510(k) Number
K170954 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Portable ECG Monitor is a Portable Electrocardiograph (Device Type: DPS – Diagnostic, Non-Power-Driven, Electrocardiograph), designed to record and display the electrical activity of the heart. It provides real-time ECG tracings for clinical assessment of cardiac rhythm, rate, and potential abnormalities, supporting diagnostic evaluation in various settings.

This device is supplied as a reusable, non-sterile medical instrument intended for use in clinical, home, or field environments. It requires no special storage conditions beyond protection from physical damage and extreme temperatures, and its design complies with FDA 510K clearance (K170954) and MDR regulatory standards. The monitor is classified under the Cardiovascular advisory committee and is intended for use by trained healthcare professionals or under their supervision.

Frequently asked questions

Is this ECG monitor meant for single-use or can it be reused in a clinical setting?

This Portable ECG Monitor is designed as a reusable device, not for single-use. Since it is classified as a non-sterile, non-disposable instrument, it must be cleaned and maintained according to standard medical device reprocessing protocols between uses. Reusability is typical for portable ECG monitors used in clinical, home, or field settings where cost efficiency and durability are priorities.

What storage requirements does the Portable ECG Monitor have, and can it be kept in a home environment?

The device does not require specialized storage conditions beyond protection from physical damage and extreme temperatures. This means it can be safely stored in a home environment, provided it is kept in a stable, dry location away from direct sunlight or moisture. Its design ensures it is durable enough for use in clinical, home, or field settings without needing refrigeration or humidity-controlled environments.

What regulatory pathways has this device followed, and which committee reviewed its submission?

The Portable ECG Monitor was cleared through the FDA 510(k) pathway under the classification of Diagnostic, Non-Power-Driven, Electrocardiograph (DPS). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the device was determined to be substantially equivalent to a predicate device. Additionally, it complies with MDR (Medical Device Regulation) standards, ensuring it meets both U.S. and EU regulatory requirements.

How does the device support clinical assessment, and what kind of electrical activity does it record?

This Portable ECG Monitor records and displays the electrical activity of the heart in real-time, allowing clinicians to assess cardiac rhythm, heart rate, and potential abnormalities. It is designed for diagnostic evaluation in various settings, including clinical, home, or field environments, providing essential data for identifying arrhythmias, conduction issues, or other cardiac irregularities under the supervision of trained healthcare professionals.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Contec Medical Systems Co., Ltd.
FDA Applicant
Contec Medical Systems Co.,Ltd

Sources (2)

  • FDA 510(k) K170954 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 20, 2026