Alvita TMB-1117-S

Device Model:

TMB-1117-S

Manufacturer:

OBL: Alliance Unichem IP Ltd. (Alvita), 2 The Heights, Brooklands, Weybridge, Surrey KT13 0NY, UNITED KINGDOM.

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:

Wrist

Measurement Occurrence:

Single measurements only

Availability:

Not made available

Description:

The Alvita TMB-1117-S 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 wrist. It is intended for self-measurement and home use.

Assessment:

While the technology used in the Alvita TMB-1117-S, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Self-measurement	Manufacturer declaration of equivalence to the Transtek TMB-988

Device Family:

Alvita TMB-1117-SB, Duronic BPM-300B, HoMedics BPW-1000-EUB, Kinetik WBP3B, Kinetik TMB-1117-SB, Terraillon TMB-988Z, Transtek TMB-988B
Legend: B BIHS Derivative, Z Almost Certain

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-988

Tian HY, Liu WJ, Li SG, Song Z, Gong W. Validation of the TRANSTEK TMB-988 wrist blood pressure monitor for home blood pressure monitoring according to the International protocol. Blood Press Monit. 2010 Dec;15(6):326-8. doi: 10.1097/MBP.0b013e32833f56fb. PMID: 20827174.

ESH-IP:2002 - Pass General population