OBL: Hill-Rom Holdings Inc., Suite 1000, 130 East Randolph Street, Chicago, IL 60601, UNITED STATES.
OEM: Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.
Former: Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.
Accuracy Assessment | Recommendation | Basis | |
BP | Medaval | Recommended in certain condition(s) | Validation in specific condition(s). See publications for details. |
BP | Stride BP | Self-measurement for adults (Preferred) | Published evidence |
BP | AMA VDL (US) | Office use | Published evidence plus 510(k) K161886 |
BP | FDA (US) | 510(k) | 510(k) K161886 |
Consumer Body | Year(s) | Level | Comment | |
BP | Amazon Best Sellers (US) | Latest: 2019 | A (3.8 / 5) |
Legend: B BIHS Derivative, D DET Equivalence, P Stride Equivalence, F FDA 510(k), Z Almost Certain
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)
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 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