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Kinetik BPM1K

Device Name:BPM1K
Manufacturer:Kinetik Medical Devices Limited, Lockeridge House, Lockeridge, Marlborough, Wiltshire SN8 4EL, UNITED KINGDOM.
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
Assessment:

While the technology used in the Kinetik BPM1K, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4 but the results of the assessment on which the declaration has been based have not been published either and cannot be verified. However, there are validation studies proving clinical validation of the same measurement technology, according to other equivalence claims.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Previous recommendation, now archivedManufacturer declaration of equivalence to a device without published evidence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Kinetik BPM1CB, Kinetik BPM1KB, Kinetik BPM1KTLB, Lloyds LBP1B, Lloyds LBPK1B (B BIHS Derivative)
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.

Kinetik BPM1C

Schwartz CL, Edwards K, Gamble W, Kirkham A, Lacy P, Lewis P, McDonagh STJ, Peers C, Sheppard JP, Swales P, Howarth J, Williams B. Validation of the Kinetik Blood Pressure Monitor-Series 1 for use in adults at home and in clinical settings, according to the 2002 European Society of Hypertension International Protocol on the validation of blood pressure devices. J Hum Hypertens. Epub: 2020 Nov 22. doi: 10.1038/s41371-020-00445-9. PMID: 33223524.

ESH-IP:2002 General population (Note: ESH-02 not recognised since 01 July 2011)