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Product Labeling Information

for the LINDERA Mobility Analysis App
 
Last updated: November 7, 2024

LINDERA Mobility Analysis App

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A medical device for identifying and reducing individual fall risk factors in persons requiring care.

FOR US USERS: This product has not been evaluated by the U.S. Food and Drug Administration (FDA). This medical device is authorized for use in the European Union under the Medical Device Regulation (EU) 2017/745 but does not have FDA clearance for use in the United States.

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Version: 10.30.0
Manufacturing Date: 07.11.2024

Manufacturer Information:

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Manufacturer: LINDERA GmbH

Address: LINDERA GmbH, Modersohnstr. 34, 10245 Berlin, Germany

Contact: hello@lindera.de | +49 (0)30 120 642 57

Regulatory Status: CE marked under EU MDR 2017/745

FDA Status: Not cleared by FDA for use in United States
Quality Certification: ISO 13485 certified manufacturer

 

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CE Marking:

The LINDERA Mobility Analysis App is currently approved as a medical device of Risk Class I according to Directive 93/42/EEC (MDD) Annex IX, Rule 12. The product is in transition to Risk Class IIa according to Regulation (EU) 2017/745 (MDR).

For US Users:

  • FDA Status: This device is not cleared by the U.S. Food and Drug Administration
  • EU Authorization Only: CE marking indicates compliance with European medical device regulations
  • Use Disclaimer: Use in the United States is at user's discretion and risk

UDI-Code:

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Basic UDI-Code: 042556414LC-MAWL

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Product Description:

The LINDERA Mobility Analysis App was developed to identify and reduce individual fall risk factors in persons requiring care. It is intended for persons aged 60 and above who exhibit increased fall risk or limited mobility. The app analyzes users' gait parameters using artificial intelligence and digital questionnaires.

It is suitable for users who are able to walk a distance of at least three meters with or without assistance.

The goal of the application is to prevent falls and maintain users' mobility long-term through scientifically based recommendations.

Regulatory Classification:

  • EU Classification: Risk Class I according to MDD 93/42/EEC Annex IX Rule 12
  • Current Status: Transitioning to Risk Class IIa according to MDR 2017/745
  • Transition Period: Since July 2024, in transition phase to MDR 2017/745 certification
  • US Status: Not cleared by FDA for use in the United States

This regulatory transition information demonstrates the evolving classification of digital health technologies in Europe, where software-based medical devices are receiving increased scrutiny and higher risk classifications.

User Manual: 

• Download User Manual (PDF)

Warnings and Safety Information:

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Safety Information: This app should only be used under appropriate supervision by qualified healthcare professionals or trained family caregivers.

  • Conduct the analysis in a safe environment on non-slip surfaces, clear of obstacles and tripping hazards.
  • Use your regular mobility aids (e.g., canes, walkers, or rollators) during the analysis.
  • Have another person (family caregiver or healthcare professional) assist with video recording if needed to ensure safe completion of the gait analysis.
  • This analysis identifies potential fall risk factors but cannot predict when falls will occur. Always consult with your healthcare provider to discuss identified risks and recommended interventions.

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Important Notice: This app is designed for care recipients with mobility limitations and older adults.

  • The LINDERA Mobility Analysis App does not replace professional medical diagnosis or treatment. Always consult with your healthcare provider, physician, or nursing professional if you have questions or health concerns.
  • Individuals with severe visual impairments should not use the app without assistance, as this may compromise the analysis procedure and result accuracy.
  • Individuals with hearing impairments should use the app with caregiver supervision to ensure proper understanding and implementation of instructions.
  • Analysis results may cause anxiety or emotional distress in some users. If you experience concerns about your results, please discuss them with your healthcare provider or mental health professional.

Storage and Expiration:

Not applicable - This is a software application distributed through mobile app stores for smartphones and tablets.

Declaration of Conformity:

The LINDERA Mobility Analysis App meets the applicable requirements of Directive 93/42/EEC (MDD) and is transitioning to MDR compliance.

For US Users:

  • EU Compliance Only: This declaration covers European medical device regulations
  • FDA Status: No FDA declaration of conformity available - device not cleared for US market
  • Regulatory Notice: Use in United States is not authorized by FDA