Device Model:
LD-588
Manufacturer:
OBL: CIGA Healthcare Ltd. (Suresign), Kildowney House, Pennybridge Industrial Estate, Ballymena BT42 3HB, Co. Antrim, UNITED KINGDOM.
OEM: Shanghai Honsun International Trade Co. Ltd., Room C. Floor 22, Zhiyuan Building, 768 Xietu Road, Shanghai 200023, CHINA.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Suresign LD-588 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 upper arm. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Suresign LD-588, 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 Honsun LD-578 |
Device Family:
BIOS BD204 (Precision 4.0)D,
Honsun Scian LD-533B,
Honsun Scian LD-520B,
Honsun Scian LD-522B,
Honsun Scian LD-528B,
Honsun Scian LD-530B,
Honsun Scian LD-532B,
Honsun Scian LD-562B,
Honsun Scian LD-568 (V1)B,
Honsun Scian LD-578B,D,
Honsun Scian LD-582B,
Honsun Scian LD-586NB,
Honsun Scian LD-587B,
Honsun Scian LD-588B,
Honsun Scian LD-526B,
Honsun LD30B,
Honsun LD3B,
Little Doctor LD51AB,
Little Doctor LD51UB,
Little Doctor LD51B,
Little Doctor LD51SB,
Little Doctor LD-521AB,
Little Doctor LD-521B,
Medipro MP-BP-BPMB,
Suresign LD3B,
Suresign LD-588B,
Timesco D05.230ZLegend:
B BIHS Derivative,
D DET Equivalence,
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.
Honsun Scian LD-578
Zhang Y, Wang J, Huang QF, Sheng CS, Li Y, Wang JG. Validation of the HONSUN LD-578 blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2009 Jun;14(3):128-31. doi: 10.1097/MBP.0b013e32832ce149. PMID: 19454866.
ESH-IP:2002 - Pass General population
