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Textronics ECG Electrode

by Textronics, Inc.

510(k) K071576

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071576 Date2 Nov 2007ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Textronics ECG Electrode is an electrocardiograph electrode used for general electrocardiograph monitoring and recording procedures. It is used with ECG instruments for applications including resting ECGs, exercise ECGs, and ambulatory monitoring.

The device is supplied for use in various settings and is classified as a Class 2 device with a product code of DRX. It has been found to be substantially equivalent and has an FDA 510K clearance with the number K071576. The device is indicated for both prescription and over-the-counter use.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Textronics ECG Electrode used for?

    The Textronics ECG Electrode is used for general electrocardiograph monitoring and recording procedures, including resting ECGs, exercise ECGs, and ambulatory monitoring, with ECG instruments.

  • Is the Textronics ECG Electrode available for prescription and over-the-counter use?

    Yes, the Textronics ECG Electrode is indicated for both prescription and over-the-counter use, providing flexibility in its application.

  • What is the regulatory classification of the Textronics ECG Electrode?

    The Textronics ECG Electrode is classified as a Class 2 device with a product code of DRX, and it has been found to be substantially equivalent with an FDA 510K clearance.