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Omron HEM-7200 (V1)
Device Model:
HEM-7200
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
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
Availability according to Countries or Regions:
Australia and Japan
Description:
The Omron HEM-7200 (V1) 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. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:
While the technology used in the Omron HEM-7200 (V1), 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 have been 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.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None While a clinical validation is claimed, it cannot be checked properly.
BP Japanese Society of Hypertension Self-measurement (2016-2021) Implied equivalence to the Omron M2 (HEM-7117-E), M3 (HEM-7200-E) or M6 (HEM-7211-E)
Consumer BodyYear(s)LevelComment
BP Choice (Australia) Previous A
Device Family:
Omron HEM-7114J, Omron HEM-7200 (V1)J, Omron HEM-6200J, Omron HEM-7210J
Legend: J JHS Implied Equivalence