HoMedics BPW-1000-EU
Device Model:
BPW-1000-EU
Manufacturer:
OBL: HoMedics Inc., 3000 Pontiac Trail, Commerce Township, MI 48390, 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:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Discontinued but still available
Device Manual:
Description:
The HoMedics BPW-1000-EU is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the HoMedics BPW-1000-EU, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, 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.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
| BP | BIHS (UK and IRL) | Self-measurement | Manufacturer declaration of equivalence to the Transtek TMB-988 |
Device Family:
Alvita TMB-1117-SB, Duronic BPM-300B, HoMedics BPW-1000-EUB, Kinetik WBP3B, Kinetik TMB-1117-SB, Terraillon TMB-988Z, Transtek TMB-988B
Legend: B BIHS Derivative, Z Almost Certain
Legend: B BIHS Derivative, Z Almost Certain
Validation Publications for Equivalent Devices:
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Transtek TMB-988
Tian HY, Liu WJ, Li SG, Song Z, Gong W. Validation of the TRANSTEK TMB-988 wrist blood pressure monitor for home blood pressure monitoring according to the International protocol. Blood Press Monit. 2010 Dec;15(6):326-8. doi: 10.1097/MBP.0b013e32833f56fb. PMID: 20827174.
ESH-IP:2002 - Pass General population