Little Doctor LD12 (V2)
Device Model:
LD12
Manufacturer:
Little Doctor International (S) Pte. Ltd., 35 Selegie Road, 09-05 Parkline Shopping Centre, 188307 Singapore, SINGAPORE.
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
Device Manual:
Description:
The Little Doctor LD12 (V2) 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:
While the technology used in the Little Doctor LD12 (V2), 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 (Previous) | Manufacturer declaration of equivalence to the Honsun LD-735 |
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.
Honsun Scian LD-735
Kang YY, Chen Q, Li Y, Wang JG Validation of the SCIAN LD-735 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2016 Aug;21(4):255-8. Epub: 2016 April 18. doi: 10.1097/MBP.0000000000000192. PMID: 27093702.
ESH-IP:2010 - Pass General population