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HoMedics Mibody 360EU

Device Name:Mibody
Device Model:360EU
Manufacturer:

OBL: HoMedics Inc., 3000 Pontiac Trail, Commerce Township, MI 48390, UNITED STATES.

OEM: Oregon Scientific Inc., 10778 SW Manhasset Drive, Tualatin, OR 97062, UNITED STATES.

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 HoMedics Mibody 360EU, 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.
 
Consumer BodyVersionQuartileComment
Which? (UK)PreviousA 

Device Family:HoMedics Mibody 360EUB, Oregon BPU 330B, Oregon Ssmart Talking (BPU321OS)B, Oregon Tunstall BPU-329B (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.

Oregon BPU 330

Li L, Zhang X, Yan C, Liang Q. Validation of the Oregon Scientific BPU 330 for self-monitoring of blood pressure according to the International Protocol. Vasc Health Risk Manag. 2008;4(5):1121-5. PMID: 19183762. Available from: PMC2605325.

ESH-IP:2002 - Pass General population