1byOne TMB-1585-BS
Device Model:
TMB-1585-BS
Manufacturer:
Brand: Ascend Eagle Inc., 828 San Pablo Ave., Pinole, California 94564-2333, UNITED STATES.
Distributer: 1byOne Products Inc., 2313 E Philadelphia St, Ontario, CA 91761, CANADA.
OBL: 1byOne.com, 1230 E Belmont St, Ontario, CA 91761, CANADA.
OEM: Guangdong Transtek Medical Electronics Co. Ltd., Zone A, 105 Dongli Road, Torch Development District, Zhongshan 528437, CHINA.
Other: 1byOne HongKong Ltd., Suite A1, 12/F Ritz Plaza 122, Austin Road Tsim Sha Tsui, Kowloon, Hong Kong 999077, HONG KONG PRC.
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
Description:
The 1byOne TMB-1585-BS 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 1byOne TMB-1585-BS 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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
Device Family:
1byOne TMB-1585Z, 1byOne TMB-1585-BSZ, Transtek TMB-1585Z, Transtek TMB-1585-BSZ
Legend: Z Almost Certain
Legend: Z Almost Certain