Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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The World’s First Blood Pressure Measurement Mobile App Approved As Medical Device
  • Registration Date 2020-07-03
  • Hit 883
The World’s First Blood Pressure Measurement Mobile App Approved As Medical Device

Blood pressure measuring software receives the world's first medical device approval
Software that uses a smart wristwatch (mobile platform) to measure blood pressure and informs systolic/diastolic blood pressure and heart rate.
Satisfies all blood pressure and heart rate accuracy standards, the medical device performance standards for generally used automatic electronic blood pressure monitors
Measure your blood pressure with ease by using the smartwatch and app!
*Automatic electronic blood pressure monitor: Electronic blood pressure measuring device that measures arterial pressure with an expanding cuff worn on the arm

Composition and Connection Method
1) Photoplethysmography (PPG) (blood pressuring measurement app) <- adjustment (Cuff-type blood pressure monitor approved by the MFDS)
2) Results of blood pressure (blood pressuring measurement app) <- adjustment (Cuff-type blood pressure monitor approved by the MFDS)
3) bluetooth
4) settings, user guidelines, the result of blood pressure, history information (smartphone app) <- adjustment (Cuff-type blood pressure monitor approved by the MFDS)
*Photoplethysmography (PPG)
Technique where light from an LED shines on human tissue (blood vessels), measuring the blood quantity passing through the vessels

Revised "Safety Management Guidelines for Mobile Medical App" to accelerate the development of cutting-edge software medical device products
"Mobile app" medical devices
35 cases approved
In line with the 4th Industrial Revolution era, the MFDS will support a quick commercialization of the medical devices made with cutting-edge technology.


Please refer to the Press Release on April 21, 2020 for more information.
Attached File
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