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AT-Patch

ATsens Co., Ltd. · Model ATP-C130 · UDI-DI 08800069700260

DSH DQK MLO Prescription

510(k) clearances

962

Adverse events (6 deaths)

Recalls

Facilities

Description

The device is intended to measure, analyze, edit and report continuous electrocardiogram (ECG) information for longterm recording (ATP-C130: up to 14 days, ATP-C70: up to 7 days) by attaching to the patient’s torso. ECG records are saved in the device during use and are not intended for real-time monitoring. After the wear period is completed, the ECG data is transmitted to the AT-Report. A primary analysis is performed by the algorithms within the AT-Report, and then a physician report is issued based on those results after a secondary analysis by a clinician or trained operator with experience in ECG analysis to correct any incorrectly detected events. The Physician report is offered to clinicians or physicians on an advisory basis only.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.