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Proton PHCP-868BF

Proton PHCP-868BF
Device Model:PHCP-868BF
Manufacturer:

OBL: Proton Healthcare, 2118 US Highway 41, Calhoun, GA 30701, UNITED STATES.

OEM: Health & Life Co. Ltd., 9F - 186 Jian 1st Rd., Zhonghe Dist., New Taipei City 23553, TAIWAN PRC.

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
Click here to download the Device Manual
Description: The Proton PHCP-868BF is a clinically validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use.
Assessment:

While the technology used in the Proton PHCP-868BF, 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.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.
BIHS (UK and IRL)Self-measurementManufacturer declaration of equivalence
ESH (Europe)Self-measurementThe BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

Device Family:Beurer BM 26P, Beurer BM 35D,P, Beurer BM 40P, Braun BP-4900D, Braun BP-5900D, H&L HL868BAB,D, Hartmann Veroval BP750X (2-in-1 ECG)P, Proton PHCP-868BFB, Seagull S-868BAB, Sejoy BP-1307P, Spengler Tensonic ArmP (B BIHS Derivative, D DET Equivalence, P Stride 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.

H&L HL868BA

Chen HE, Cui Y, Sheng CS, Li LH, Li Y, Wang JG. Validation of the Health & Life HL868BA blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol. Blood Press Monit. 2008 Oct;13(5):305-8. doi: 10.1097/MBP.0b013e32830d4bd0. PMID: 18799958.

ESH-IP:2002 - Pass General population

Sejoy BP-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