Skip to content

ECG recorder and Arrhythmia Detector

by Smart Solutions Technologies SL

510(k) K173461

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 NumberK173461 Date3 Aug 2018ClearedStatusActive

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  • Withdrawn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
DSH
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

An ECG recorder and arrhythmia detector is a wearable ambulatory ECG monitor that consists of a textile chest-belt with electrodes, a recorder unit, and analysis software. It records 2-lead ECG and 3-axis accelerometer data for up to 30 days, allowing patients to trigger symptom markers, with data stored on a micro SD card for later download to a PC for analysis.

The device is supplied as a system including the Nuubo30 textile chest-belt, NuuboREC recorder, and Nuubo Leonardo analysis software. It is intended for use in ambulatory settings, with data stored on a micro SD card and downloaded to a PC for analysis. The device has received FDA 510(k) clearance under K173461 and is classified as a Class II medical device under regulation number 870.2800.

Questions

AI-generated answers, 25 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 ECG recorder and Arrhythmia Detector used for?

    It is used to record 2-lead ECG and 3-axis accelerometer data for up to 30 days in ambulatory settings, allowing patients to trigger symptom markers during daily activities for later analysis of cardiac rhythms and arrhythmias.

  • How is the ECG recorder and Arrhythmia Detector supplied and what components are included?

    It is supplied as a complete system comprising the Nuubo30 textile chest-belt with integrated electrodes, the NuuboREC recorder unit, and the Nuubo Leonardo analysis software, all designed to work together for ambulatory monitoring and data evaluation.

  • How is data stored and retrieved from the ECG recorder and Arrhythmia Detector?

    Data is stored locally on a micro SD card within the recorder unit during monitoring and must be physically downloaded to a PC using the Nuubo Leonardo software for analysis, as the device does not support wireless transmission or real-time streaming.