Device Model:
BP-1305
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 and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The LotFancy BP-1305 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:
There appears to be no peer-reviewed clinical validation information available on the technology used in the LotFancy BP-1305 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:
Aspen BP-10 (BP-103H)Z,
Beurer BM 26P,
Beurer BM 40P,
Beurer BM 35/1D,P,
Braun BP-4900D,
Braun BP-5900D,
Healthcare World BP-103HZ,
Hartmann Veroval 2-in-1 ECG (BP750X)P,
HyMark DBP-1314 (BP-103H)Z,
LotFancy BP-103HZ,
LotFancy BP-1305Z,
Sejoy Joytech DBP-1204 (Sejoy BP-102)F,
Sejoy Joytech DBP-1314 (Sejoy BP-103H)F,
Sejoy Joytech DBP-1209 (Sejoy BP-1209)F,
Sejoy Joytech DBP-1303 (Sejoy BP-1303)F,
Sejoy Joytech DBP-1305 (Sejoy BP-1305, Joytech DBP-1305)F,
Sejoy Joytech DBP-1307 (Sejoy BP-1307, Joytech DBP-1307)B,P,F,
Sejoy Joytech DBP-1231F,
Sejoy Joytech DBP-1332F,
Sejoy Joytech DBP-1334F,
Spengler AutoTensio Arm (SPG440)P,
Spengler Tensonic ArmP,
Xuerui XR-BP-102Z,
Xuerui XR-BP-103HZ,
Xuerui XR-BP-1209Z,
Xuerui XR-BP-1303Z,
Xuerui XR-BP-1305Z,
Xuerui XR-BP-1307ZLegend:
B BIHS Derivative,
D DET Equivalence,
P Stride Equivalence,
F FDA 510(k),
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.
Sejoy Joytech DBP-1307 (Sejoy BP-1307, Joytech DBP-1307)
Lei L, Chen Y, Chen Q, Li Y, Wang JG. Validation of the SEJOY BP-1307 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2017 Dec;22(6):371-4. Epub: 2017 Aug 03. doi: 10.1097/MBP.0000000000000283. PMID: 28786853 .
ESH-IP:2010 - Pass General population
