LotFancy 11C-1863-Q2

Device Model:

11C-1863-Q2

Manufacturer:

Brand: LotFancy, ℅ Ding Heping, 1113 Lane, 2729 Road, Hunan, Shanghai, CHINA.

OBL: LotFancy Inc., Suite D, 330 Shaw Road, South San Francisco, CA 94080, UNITED STATES.

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 LotFancy 11C-1863-Q2 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 LotFancy 11C-1863-Q2 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:

AViTA BPM15 (v1)Z, AViTA BPM11 (v2)P, AViTA BPM15 (v2)Z, AViTA BPM15SP, LotFancy 11C-1863-Q2Z
Legend: P Stride 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.

AViTA BPM15S

Kang YY, Zeng WF, Zhang L, Li Y, Wang JG. Validation of the AVITA BPM15S wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2014 Jun;19(3):183-6. doi: 10.1097/MBP.0000000000000041. PMID: 24695213.

ESH-IP:2010 - Pass General population