Torm KD-7920
Device Model:
KD-7920
Manufacturer:
OBL: Laboratoire Cooper (Torm), Place Lucien Auvert, 77020 Melun cedex (2 rue de la Saussaie, 77310 Ponthierry), FRANCE.
OEM: Andon Health Co. Ltd., 3 Jinping Road, Ya'an Street, Nankai District, Tianjin 300190, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Wrist
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Torm KD-7920 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.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Torm KD-7920 to measure blood pressure. However, this device appears to be very similar to a validated device by the same (OEM) manufacturer or a device within a family of equivalent devices, but 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 | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. |
Device Family:
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.
Andon KD-7920
Li D, Li Y, Li J, Gu Y, Shang F. Validation of the ANDON KD-7920 wrist blood pressure monitor in general population according to the ISO 81060-2:2018+AMD1:2020 protocol. Blood Press Monit. Epub: 2024 Dec 24. doi: 10.1097/MBP.0000000000000740. PMID: 39831765.
81060-2:2020 - Pass General population