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Oregon Ssmart Talking (BPU321OS)

Device Name:Ssmart Talking BPM
Device Model:BPU321OS
Manufacturer:

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

OEM: IDT Technology Ltd., Block C, 9/F Kaiser Estate Phase 1, 41 Man Yue Sheet, Hung Hom, Kowloon, HONG KONG PRC.

Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Device Accessibility:Voiced instructions and results
Availability:Discontinued but still available
Assessment:

While the technology used in the Oregon Ssmart Talking (BPU321OS), 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 there is no evidence provided on a validation of the other device.

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: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