Proton PHCP-868BF - Medaval

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 ROC.

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

Device Manual:

Click here to download the Device Manual

Description:

The Proton PHCP-868BF 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:

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	BIHS (UK and IRL)	Self-measurement	Manufacturer declaration of equivalence
BP	ESH (Europe)	Self-measurement	The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.

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, H&L HL868BAB,D, Hartmann Veroval 2-in-1 ECG (BP750X)P, HyMark DBP-1314 (BP-103H)Z, LotFancy BP-103HZ, LotFancy BP-1305Z, Proton PHCP-868BFB, Seagull S-868BAB, 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-1307Z
Legend: 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.

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 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