CareSimple BT-105
Device Model:
BT-105
Manufacturer:
OBL: CareSimple Inc., Suite 600, 3801 PGA Boulevard, North Palm Beach, FL 33410-2756, UNITED STATES.
OEM: Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.
Measuring functions:
Blood Pressure and PR
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 CareSimple 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:
While the technology used in the CareSimple BT-105, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has 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, but there is no evidence provided on a validation of the other device.
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