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Transtek TMB-1776
Device Model:
TMB-1776
Manufacturer:
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
Device Accessibility:
Large text
Availability:
Available Currently
Description:
The Transtek TMB-1776 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Transtek TMB-1776, 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 AssessmentRecommendationBasis
BP Medaval ★★ Recommendation Recent clinical validation; recent protocol
BP BIHS (UK and IRL) Self-measurement Published evidence
BP Stride BP Self-measurement for adults Published evidence
Device Family:
Braun ExactFit 3 (BP-6000)B,D, Braun ExactFit 5 (BP-6200)B,D, Braun ExactFit 3 (BP-6100)B,D, Medicare Lifesense A5 (MD1806)B,P, Medicare Lifesense A1 (MD1814)B, HoMedics BPA-2000-EUB, HoMedics BPA-3000-EUB, Kinetik TMB-1970B, Kinetik TMB-2088B, Omron HEM-780N3F, Transtek LS802-BF, Transtek TMB-1018F, Transtek TMB-1018BTF, Transtek TMB-1112AF, Transtek TMB-986B,D,F, Transtek TMB-1776B,P, Transtek TeleRPM BPM Gen 1 (LS802-GS)P,F, Transtek LS802-GPP, Hillrom 1500 (RPM-BP100)Z, Hillrom Home 1700 (H-BP100SBP)F, Hillrom ProBP 2000Z
Legend: B BIHS Derivative, D DET Equivalence, P Stride Equivalence, F FDA 510(k), Z Almost Certain
Validation Publications:

Liu Z, Chen L. Validation of Transtek TMB-1776 according to European Society of Hypertension International Protocol revision 2010 in adults. Blood Press Monit. 2019 Dec;24(6):319-322. Epub: 2019 Sep 26. doi: 10.1097/MBP.0000000000000406. PMID: 31567185.

ESH-IP:2010 - Pass General population

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.

Hillrom 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 Adult subjects whose oscillometric pressures were augmented with simulator-produced tremors. (n=85)

Hillrom ProBP 2000

Alpert BS. Validation of the Welch Allyn Pro BP 2000, a professional-grade inflation-based automated sphygmomanometer with arrhythmia detection in a combined pediatric and adult population by ANSI/AAMI/ISO standard testing. Blood Press Monit. 2018 Dec;23(6):315-317. Epub: 2018 Oct 11. doi: 10.1097/MBP.0000000000000350. PMID: 30312180.

81060-2:2013 - Pass Adults (n=53) and children (n=35)

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

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