Terraillon TMB-988

Device Model:

TMB-988

Manufacturer:

OBL: Terraillon SAS, 1 rue Ernest Gouin, 78293 Croissy-sur-Seine, FRANCE.

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:

Available Currently

Description:

The Terraillon TMB-988 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:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Terraillon TMB-988 to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer or a device within a family of equivalent devices, but equivalence needs to be proven 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.

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