Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)

The Arm-type Fully Automatic Digital Blood Pressure Monitor (seven models: DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) is an automatic, noninvasive blood pressure measurement system for home and clinical use. It measures systolic and diastolic pressure using the oscillometric method with an electric pump and automatic deflation valve, and some models include Bluetooth connectivity to transmit readings to a companion app that displays results only—without diagnostic or measurement functions.

The subject devices use identical oscillometric measuring principles, measurement type during inflation, upper-arm cuff location, and body-worn classification as the predicate (Omron Evolv BP7000). Pressure accuracy is ±3 mmHg for both. Minor differences include slightly broader operating humidity range (15–93% vs. 15–90%), expanded cuff circumference capability in some models (22–42 cm), varying power sources (lithium battery or AC adapter options vs. AAA batteries only), and memory capacity of 2×120 readings vs. unspecified memory in predicate.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (general electrical safety), IEC 80601-2-30:2018 (automated noninvasive sphygmomanometers), IEC 60601-1-11:2015+AMD1:2020 (home healthcare equipment), IEC 60601-1-2:2014+AMD1:2020 (electromagnetic compatibility), ISO 10993-5:2009 and ISO 10993-10:2010 (biocompatibility), ISO 81060-2:2018+AMD2020 (clinical validation), FCC Part 15 Subpart C, and IEC 62133-2 (lithium battery testing).

The devices share the same measuring principle (oscillometric), measurement type (determined during inflation), intended patient population (adults and adolescents over 12 years), and regulatory classification as the predicate. Clinical validation using 90 subjects per ISO 81060-2 demonstrated accuracy within acceptable limits. Although the subject devices are body-worn versus the predicate's portable form and include optional Bluetooth/lithium battery variants, these differences do not raise new safety or effectiveness issues because the core measurement algorithm, cuff mechanics, and performance specifications remain identical, and all variations have been tested against applicable safety standards.