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Braun ExactFit 5 (BP-6200)

Braun ExactFit 5 (BP-6200)
Device Name:ExactFit 5
Device Model:BP-6200
Manufacturer:

OBL: B. Braun Melsungen AG, Carl-Braun-Straße, 134212 Melsungen, GERMANY.

OEM: Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.

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
Description: The Braun ExactFit 5 (BP-6200) is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

The technology used in the Braun ExactFit 5 (BP-6200), to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementPublished evidence
 
Consumer BodyVersionQuartileComment
Stiftung Warentest (DE)Most recent: 2018-2020Satisfactory 
Which? (UK)Most recent: 2014-2021B 

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 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

Welch Allyn Home 1700 (H-BP100SBP)

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.