Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)

The wrist automatic blood pressure monitor (models LD-735, LD-752, LD-753) is a non-invasive device that automatically measures systolic and diastolic arterial blood pressure and pulse rate in adults aged 15 and above. It uses an oscillometric method where a wrist cuff inflates via an electric pump, and software algorithms analyze pressure waveforms to determine blood pressure values.

All three models use the oscillometric method with automatic pump inflation and electronic valve deflation. LD-735 has a smaller main body (62×61×25 mm) and single memory group of 90 readings; LD-752 and LD-753 have identical specifications (66×70×30 mm) with dual memory groups (2×90 readings each) and additional functions including date/time, WHO classification, and irregular heartbeat detection. All operate at 5–40°C, 15–90% RH, with 2×AAA batteries.

ANSI AAMI ES 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment), ISO 80601-2-30 (non-invasive sphygmomanometers), ISO 10993-1 and ISO 10993-5/10 (biocompatibility), and FDA software verification and validation guidance (May 2005).

The subject devices share identical intended use, measuring principle, cuff location, accuracy (±3 mmHg; ±5% pulse), and operating specifications with predicate LD-737 (K131463). Differences in body dimensions, weight, and added features (LD-752/753) do not raise new safety or effectiveness issues. Nonclinical testing demonstrates comparable performance, and biocompatibility is unchanged since patient-contact materials are identical to the predicate.