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…
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.
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for AT-Patch | Listed by | ATsens Co., Ltd., South Korea |
| FDA product code | DSH |
| Device type | Recorder, Magnetic Tape, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Manufacturer |
| 510(k) | K242583 |
| Record published | 2025-11-05 |
| Record revised | 2025-11-28 (version 3) |
Specifications
Specifications | MRI safety | MR Unsafe |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 10, pack of 8 |
| Distribution end date | 2025-10-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.