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Transtek TMB-1112A
Device Model:
TMB-1112A
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
Availability:
Available Currently
Description:
The Transtek TMB-1112A is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. 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-1112A, to measure blood pressure, has 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP FDA (US) 510(k) 510(k) K120058
Device Family:
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-1776

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

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