Legal and Regulatory

Medical Device Information

Medical device details, intended use, safety information, instructions for use, and legal notices for this application.

Medical device details

Reference symbolDevice name
PROTECT Digital Health Platform (implementing the REACTIVE application).
Lot symbolSoftware version / build number
R1 / V2
Date of manufacture symbolDate of manufacture
Not configured
Manufacturer symbolManufacturer (registered company name)
University of Exeter
Manufacturer symbolManufacturer place of business
PROTECT Team
Health and Community Sciences
College House 1.23
St Luke's Campus
Heavitree Road
Exeter
Devon
EX1 2LU
United Kingdom
reactive@exeter.ac.uk
01392 727581

Medical device for research and investigational purposes only.

Intended use and indications for use

To monitor cognition and dementia risk and provide an early warning system for clinically meaningful cognitive decline for older adults aged 65 years and over living in the community.

Indications: For older adults aged 65 years and over living in the community.

Caution symbol

Cautionary and safety information

  • PROTECT Digital Health Platform (implementing REACTIVE) is not a diagnostic tool. Do not use PROTECT Digital Health Platform (implementing REACTIVE) to diagnose or treat any medical condition. If you are concerned about your memory, thinking, mood or any other symptoms, seek advice from an appropriate healthcare professional.
  • Full warnings, precautions and operating instructions are provided in the Instructions for Use. Please read the instructions for use before using the device.
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Instructions for use symbol

Instructions for use (IFU)

Please read and review the instructions for use for important information regarding the safe and effective use of this application.

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Legal notices

Open source licenses: view licenses