BodyTrace BT-105
Device Model:
BT-105
Manufacturer:
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.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
Description:
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.
Assessment:
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 or a device within a family of equivalent devices. 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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
| BP | AMA VDL (US) | Self-measurement | Equivalence claim without published evidence |
Device Family:
BodyTrace BT-105Z, BodyTrace BT-106Z, CareSimple BT-105Z, CareSimple BT-106Z
Legend: Z Almost Certain
Legend: Z Almost Certain