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EZYPRO ECG Recorder (Model UG02)

by Sigknow Biomedical Co., Ltd.

510(k) K213233

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213233↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK213233 Date23 Jun 2022ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
DRG
Device Class
Class II
Regulation
21 CFR Part 870.2910
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 EZYPRO ECG Recorder (Model UG02) is a Transmitter and Receiver, Physiological Signal, Radiofrequency device designed for continuous single-lead cardiac monitoring. It records electrocardiogram (ECG) signals wirelessly, enabling long-term arrhythmia detection and remote transmission of cardiac data for diagnostic evaluation.

This device is intended for single-patient use and is supplied as a non-sterile, reusable system (with disposable electrodes). It operates in outpatient or home settings, offering configurable monitoring durations of 1, 3, 7, or 14 days. Authorized under FDA 510(k) clearance (K213233) and MDD compliance, it adheres to Class II – Special Controls (Regulation 870.2910) and includes radiofrequency transmission for data transfer. Storage and handling follow manufacturer guidelines for reusable components.

From the manufacturer

Portable heart rhythm patch monitor. Customize 1, 3, 7, and 14-day monitoring period integrated with professional ECG analysis service. The one-stop arrhythmia diagnostic solution for physicians.

Source: sigknow.com

Other devices from Sigknow Biomedical Co., Ltd.

See all devices from Sigknow Biomedical Co., Ltd. →

Questions

AI-generated answers, 18 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 types of settings can the EZYPRO ECG Recorder be used in, and what makes it suitable for those environments?

    The EZYPRO ECG Recorder (Model UG02) is designed for use in outpatient or home settings, making it ideal for continuous cardiac monitoring outside traditional clinical environments. Its wireless single-lead ECG recording and remote data transmission capabilities enable long-term arrhythmia detection, which is particularly useful for patients who require monitoring over extended periods (configurable up to 14 days) without needing to be confined to a hospital or clinic.

  • Is the EZYPRO ECG Recorder reusable, and if so, what components are disposable?

    Yes, the EZYPRO ECG Recorder is a reusable system, but it requires disposable electrodes for single-patient use. The reusable components include the transmitter and receiver units, while the electrodes are intended to be discarded after use to maintain hygiene and ensure accurate signal transmission.

  • What monitoring durations are available with the EZYPRO ECG Recorder, and how does this flexibility benefit clinicians?

    The EZYPRO ECG Recorder offers configurable monitoring durations of 1, 3, 7, or 14 days, allowing clinicians to tailor the monitoring period based on patient needs. This flexibility is particularly beneficial for detecting intermittent arrhythmias or assessing cardiac conditions over extended periods without requiring frequent clinic visits or hospital stays.

  • How is the device’s sterility maintained, and what does this mean for its use in clinical or home settings?

    The EZYPRO ECG Recorder itself is supplied as a non-sterile, reusable system, but it is paired with disposable electrodes to ensure sterility for single-patient use. This design minimizes cross-contamination risk while allowing the reusable components to be cleaned and reused between patients, making it suitable for both clinical and home monitoring environments.

  • What regulatory pathways has the EZYPRO ECG Recorder followed, and what does this indicate about its compliance standards?

    The EZYPRO ECG Recorder has been authorized under both FDA 510(k) clearance (K213233) and the Medical Devices Directive (MDD), adhering to Class II – Special Controls under FDA regulation 870.2910. This indicates that the device meets stringent compliance standards for safety and performance, ensuring it is suitable for use in cardiac monitoring applications as intended.