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Rossmax Accumed CH91

Device Name:Accumed
Device Model:CH91
Manufacturer:

Brand: Rossmax Swiss GmbH (Accumed), Tramstrasse 16, CH-9442 Berneck, SWITZERLAND.

Sole: Rossmax International Ltd., 12F - 189 Kang Chien Road, Taipei 114, 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:Discontinued but still available
Description: The Rossmax Accumed CH91 is a non-clinically-validated semi-automatic surface-placed blood pressure monitor. Measurements are taken from the upper arm and it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Rossmax Accumed CH91 to measure blood pressure. However, this device appears to be very similar to another device by the same (OEM) manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not shown to have been clinically validated.

Device Family:Rossmax Accumed CH91Z, Rossmax CH91 (V1)Z, Rossmax CH91 (V2)Z (Z Almost Certain)