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Welch Allyn Home 1700 (H-BP100SBP)

Device Name:Home 1700
Device Model:H-BP100SBP
Manufacturer:Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

The technology used in the Welch Allyn Home 1700 (H-BP100SBP), to measure blood pressure, has passed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication. It has also been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalRecommended in certain condition(s)Validation in specific condition(s). See publications for details.
Stride BPSelf-measurement for adults (Preferred)Published evidence
AMA VDL (US)Self-measurementPublished evidence plus 510(k) K161886
 
Consumer BodyVersionQuartileComment
Amazon Best Sellers (US)2019A (3.8 / 5) 

Device Family:Braun ExactFit 3 (BP-6000)B,D, Braun ExactFit 3 (BP-6100)B,D, Braun ExactFit 5 (BP-6200)B,D, HoMedics BPA-2000-EUB, HoMedics BPA-3000-EUB, Omron HEM-780N3F, Transtek LS802-BF, Transtek TMB-1018F, Transtek TMB-1018BTF, Transtek TMB-1112AF, Transtek TMB-986B,D,F, Welch Allyn Home 1700 (H-BP100SBP)F (B BIHS Derivative, D DET Equivalence, F FDA 510(k))
Validation Publications

Alpert BS. Validation of the Welch Allyn Home blood pressure monitor with professional SureBP algorithm with a special feature of accuracy during involuntary (tremor) patient movement. Blood Press Monit. 2019 Apr;24(2):89-92. Epub: 2019 Feb 4. doi: 10.1097/MBP.0000000000000365. PMID: 30724792.

81060-2:2013 - Pass 85 adult subjects whose oscillometric pressures were augmented with simulator-produced tremors.

Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Transtek TMB-986

Liu WJ, Li SG, Song Z, Gong W. Validation of the TRANSTEK blood pressure monitor TMB-986 for home blood pressure monitoring according to the International Protocol. Blood Press Monit. 2010 Oct;15(5):278-80. doi: 10.1097/MBP.0b013e32833e43ca. PMID: 20729726.

ESH-IP:2002 - Pass General population