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510(k) Data Aggregation
K Number
K203638Device Name
AT-Patch ECG Analysis System
Manufacturer
Date Cleared
2022-10-12
(667 days)
Product Code
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
ATsens Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to measure, save, and view continuous electrocardiogram (ECG) information for long-term recording (up to 14 days) from ambulatory patients by attaching to the skin surface. ECG records are stored in the the device for review after the recording period (up to 14 days) is completed, and are not intended for for real-time monitoring. The device does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis. The device allows patient and clinicians to view the ECG signal recorded in real-time solely for the purpose of visual assessment of the recording quality; the ECG signal displayed in real time is not intended for any clinical or diagnostic use. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.
Device Description
AT-Patch consists of 1) AT-Patch device, 2) Software for ECG viewing (ATR-C130), 3) App (ATN-C130) that communicates with the device and allows the patient to view the ECG waveform for visual assessment of the recording quality, and included parts (Dedicated Cable, BLE Dongle and USB memory). AT-Patch an ambulatory ECG recorder, designed to continuously acquire and store patient's ECG for up to 14 days. The AT-Patch can connect to the device applicaitn (ATN-C130) torecord symptoms with the App during operation and to check the ECG recording. The device is not intended for real-time monitoring.
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