FeetMe Devices

Introduction

FeetMe devices combine embedded and miniaturized sensors with smart algorithms to assess mobility in real world non invasively.

Every device can be paired with a software solution targeting different use cases:

The devices

The FeetMe insole is a solution for ambulatory gait assesment that combines pressure sensors, motion sensors and an embedded calculation power to allow real time gait parameters assesment.

  1. Wireless charging

  2. Sizes

    • 12 Sizes (from size 35 to size 46)
    • Thickness 4 mm
    • Weight 100 g

  3. Extended autonomy

    • Battery life 24hrs

  4. Embedded calculation power

    • Embedded metrics calculation

  5. Pressure sensors

    • Sample rate 100 HZ pressure

  6. Motion sensors

    • Gyroscope, accelerometer
    • Sample rate 150 Hz IMU

  7. Standalone device with internal storage

    • Data storage 13 days

  8. Wireless communication

    • Communication Bluetooth Low Energy

  9. Warrant

    • 2 years or 1 000 000 steps

Metrics and technical specifications

More than 20 metrics are calculated for every step with FeetMe® Insole:

  • metrics Stride length
  • metrics Walking speed
  • metrics Width motion
  • metrics Cadence
  • metrics Stride time
  • metrics Single support time
  • metrics Swing time
  • metrics Double support time
  • metrics Pressure distribution
  • metrics Stride length difference
  • metrics Strides time difference
  • metrics Distance traveled
  • metrics Support asymetry
  • metrics Trajectory center of pressure

Example of pressure heatmap with FeetMe® Evaluation Mobility
Example of pressure heatmap with FeetMe® Evaluation Mobility

Regulatory Requirements

FeetMe Quality Management system has certified NF EN ISO 13485:2016 & ISO 9001:2015

FeetMe Evaluation is a medical device in class Im:

  • Compliant with Directive 93/42/CEE (in transition with the medical device regulation 2017/745)
  • Compliant with CEI 60601-1 :2006 (Basic safety & essential performance of Medical electrical equipment), CEI 60601-1-2: 2014 (electromagnetic disturbances) & CEI 60601-1-11 :2010 (used in the home healthcare environment)
  • IP55
  • Compliant with ISO 62304:2006 (Software life-cycle processes)
  • Compliant with ISO 14971:2019
  • Compliant with IEC 62366-1:2015 (Usability engineering)
  • Compliant with European Regulation n° 2016/679 GDPR, and the French law loi n°78-17 January, 6 1978 concerning IT, files and freedom

Scientific validation / Data export

Our measurements have been scientifically validated in clinical setting. Our customers can easily access our data and the data can be customized based on customers needs.

Example of Data

Technical validation (in french)


For further information or studies: contact us

SDK

FeetMe can provide a SDK for its partners. For more information:

Contact us

Support and Questions

You can download user manuals and support documentation on the page Support & Downloads.

You can also consult frequently asked questions.

You can also contact us.