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CareSimple BT-106
Device Model:

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
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Connected Health Technologies:
Available Currently
Availability according to Countries or Regions:
United States
Device Manual:
The CareSimple BT-106 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 CareSimple BT-106 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.
Accuracy AssessmentRecommendationBasis
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