K-jump KP-7770

Device Model:

KP-7770

Manufacturer:

OBL: K-jump Health Co. Ltd., 56 Wu Kung 5th Rd., New Taipei Industrial Park, New Taipei City 24890, TAIWAN ROC.

OEM: Spengler S.a.s., 190 rue Paul Langevin, ZAC La Robole, 13856 Aix-en-Provence, FRANCE.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single and repeated measurements

Availability:

Available Currently

Device Specifications:

Click here to download the Device Specifications

Description:

The K-jump KP-7770 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:

The technology used in the K-jump KP-7770, to measure blood pressure, has been compared to a clinically validated device, but not 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:

HealthWorks SCLV-2007 Cardio-Vascular LabB, K-jump KP-7770D, Spengler KP7500 DB,D, Spengler TB-101B
Legend: B BIHS Derivative, D DET Equivalence

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.

Spengler KP7500 D

Belghazi J, El Feghali RN, Moussalem T, Rejdych M, Asmar RG. Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2007;3(4):389-400. PMID: 17969368. Available from: PMC2291343.

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