OBL: BodyTrace Inc., 3505 El Camino Real, Palo Alto, CA 94306, UNITED STATES.
OEM: Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.
Primary Client Use:
Intended for self-measurement and home use
Single measurements only
Connected Health Technologies:
Availability according to Countries or Regions:
The BodyTrace BT-105 is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
There appears to be no peer-reviewed clinical validation information available on the technology used in the BodyTrace BT-105 to measure blood pressure. However, this device appears to be very similar to another device by the same (OEM) manufacturer. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|BP||Medaval||Not recommended||This device has not been shown to have been clinically validated.|
|BP||AMA VDL (US)||Self-measurement||Implied equivalence to the|