AT-Patch (ATP-C130/ATP-C70)

AT-Patch is a wearable ECG recorder that continuously measures and stores electrocardiogram signals for 7–14 days by attaching to the patient's torso. After the wear period, ECG data is uploaded to AT-Report software for automated analysis followed by clinician review. The device is indicated for patients 18+ years with symptoms such as palpitations, shortness of breath, or dizziness, and reports are provided on an advisory basis only.

The subject device uses single-channel ECG recording at 250 samples/second with 10-bit resolution, BF-type electrodes, 2.4 GHz Bluetooth communication (IEEE 802.15.4), and a coin-cell battery lasting 7–14 days depending on model (ATP-C70 or ATP-C130). Compared to predicate K203638, the ATP-C70 model is new with reduced wear time (7 vs. 14 days) and lower IP rating (IP44 vs. IP57); both models share identical circuit design, signal characteristics, and RF specifications.

Electrical and EMC testing per IEC 60601-1:2005/2012, IEC 60601-2-47:2012, IEC 60601-1-2:2020, and IEC 60601-1-11:2015. Biocompatibility per ISO 10993 series. Software validation per IEC 62304:2015. Arrhythmia detection accuracy per ANSI/AAMI EC57:2012. Electrode performance per ANSI/AAMI EC12:2000. Usability per IEC 62366-1:2015 and FDA guidance.

The device is substantially equivalent to K203638 (predicate ECG recorder) because both measure, record, and analyze continuous ECG for long-term ambulatory monitoring with the same indications, prescription use, and technical principles—differences in IP rating, size, appearance, and maximum use time do not alter the device's fundamental function or safety. AT-Report is substantially equivalent to K162023 (CardioDay software) because both perform automated rule-based ECG analysis with manual clinician review for arrhythmia detection in hospital/clinic settings; although terminology and arrhythmia classification differ slightly and the subject device has higher software risk classification, the core analytical functionality and intended purpose are comparable, and performance testing demonstrates equivalent accuracy and safety.