Intended Use
LINDERA Mobility Analysis via App
Last updated: August 30, 2024
Intended Use according to 93/42/EEC (MDD) Annex IX, Rule 12 and MDR 2017/745
The LINDERA Mobility Analysis via App is a medical device developed for the identification and reduction of individual fall risk factors in persons requiring care. It is intended for persons aged 60 and above with increased fall risk or limited mobility. The app analyzes gait parameters using artificial intelligence and digital questionnaires. The application is suitable for users who can walk a short distance of at least three meters with or without assistance. The goal of the product is to prevent falls and maintain users' mobility through scientifically based recommendations.
Indication and Target Group
The LINDERA Mobility Analysis via App is intended for persons requiring care aged 60 and above who exhibit increased fall risk or whose mobility is limited. The application is suitable for persons who are able, independently or with the assistance of mobility aids or caregiving persons such as family caregivers and/or nursing professionals, to walk a short distance of three meters.
Target Users (Application Users)
The product is intended for use by the person requiring care or trained healthcare professionals such as nurses, geriatric specialists, physiotherapists, and physicians. Additionally, family caregivers can use the LINDERA Mobility Analysis via App under guidance to support fall prevention in the home environment.
Intended Use Environment
The LINDERA Mobility Analysis via App is designed for use in home environments as well as healthcare facilities, taking into consideration the safety instructions and usage conditions described in the instructions for use.
Contraindications
No contraindications are known when the product is used according to its intended purpose.
Side Effects
No side effects are known or expected when used as intended. Should you observe any side effects in connection with the use of LINDERA Mobility Analysis via App, report these immediately to your physician or psychotherapist or contact hello@lindera.de
Clinical Benefits
The LINDERA Mobility Analysis via App provides a well-founded assessment of individual fall risk factors through precise capture and analysis of gait parameters and completion of digital questionnaires.
This information is used to provide specific, evidence-based recommendations for risk reduction that aim to prevent falls and maintain users' mobility in the long term.
Notice Regarding Compliance with ISO 13485 and ISO 27001 as well as MDR 2017/745
Lindera GmbH operates as a manufacturer of medical devices in compliance with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) as well as the international standards ISO 13485 for Quality Management Systems (QMS) and ISO 27001 for Information Security Management Systems (ISMS). These certifications ensure that our products and processes meet the highest quality and safety standards and that the protection of your personal data is always guaranteed according to the strictest regulations.