Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)

The Automatic Digital Blood Pressure Monitor (models LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572, LD-569) is a non-invasive device that measures systolic and diastolic arterial blood pressure and pulse rate in adults. It uses the oscillometric method with an inflatable cuff, pump, electronic valve, and sensor to detect pressure changes and calculate blood pressure readings.

The subject device uses the same oscillometric measurement principle and intended patient population (adults) as the predicate device LD-537. Key differences include: battery type changed to 4×AA or AAA batteries (predicate used 4×AA); charging interface upgraded to Type-C/Micro USB (predicate used standard AC adapter); memory recall increased to 2×100 or 2×90 sets depending on model (predicate had 90 sets); added features include WHO blood pressure classification, voice broadcast, irregular heartbeat detector, and date/time settings on select models; operating temperature range expanded to 5–40°C (predicate 10–40°C).

ANSI AAMI ES 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment requirements), ISO 80601-2-30 (automated non-invasive sphygmomanometer requirements), ISO 10993-1 (biocompatibility evaluation), and Guidance for Software Contained in Medical Devices (May 2005).

The subject device is substantially equivalent to predicate LD-537 because both share identical patient population (adults), blood pressure measurement ranges (40–260 mmHg), pulse rate measurement ranges (40–160 beats/minute), and accuracy specifications (±3 mmHg static pressure, ±5% pulse rate reading). Both use the same oscillometric measurement principle and are intended for identical environments (hospital, clinic, home). Minor design differences (battery type, charging port, memory capacity, added features) do not affect clinical performance. Non-clinical testing confirms electrical safety and biocompatibility equivalence, and clinical data from the predicate device is directly applicable.