HealthSTATS BPro

Device Name:

BPro

Device Model:

T6200

Manufacturer:

HealthSTATS International Pte Ltd., 3 Ang Mo Kio Street, 62 08-25/26, 569139 Singapore, SINGAPORE.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for ambulatory blood pressure monitoring

Measurement Site:

Wrist

Measurement Occurrence:

Continuous measurement

Availability:

Available Currently

Device Manual:

Click here to download the Device Manual

Description:

The HealthSTATS BPro is an ambulatory blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the wrist. It is intended for ambulatory blood pressure monitoring.

Assessment:

The technology used in the HealthSTATS BPro, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Legacy approval	Older clinical validation; older protocol
BP	BIHS (UK and IRL)	ABPM	Published evidence
BP	FDA (US)	510(k)	510(k) K060315

Validation Publications:

Nair D, Tan SY, Gan HW, Lim SF, Tan J, Zhu M, Gao H, Chua NH, Peh WL, Mak KH. The use of ambulatory tonometric radial arterial wave capture to measure ambulatory blood pressure: the validation of a novel wrist-bound device in adults. J Hum Hypertens. 2008 Mar;22(3):220-2. Epub: 2007 Nov 8. doi: 10.1038/sj.jhh.1002306. PMID: 17992251. Available from: www.nature.com. Reseach Letter.

ESH-IP:2002 - Pass General population (Note: Insufficient detail provided to support result)

Relevant Publications:

Komori T, Eguchi K, Hoshide S, Williams B, Kario K. Comparison of wrist-type and arm-type 24-h blood pressure monitoring devices for ambulatory use. Blood Press Monit. 2013 Feb;18(1):57-62. doi: 10.1097/MBP.0b013e32835d124f. PMID: 23263536.

Measurements from the HealthSTATS BPro are compared to those from the A&D TM-2431, though not in a formal validation.