FDA Brief: Week of Mar 14, 2016

FDA approved


 

exo

INDEGO Powered Lower Extremity Exoskeleton

Parker Hannifin Corporation,  US

 

Intended Use : Powered Exoskeleton

Indication for Use:  

Orthotically fits to the lower limbs and the trunk

Enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program.

The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program.

Not intended for sports or stair climbing.

Reg Pathway: Class II 510(k), Predicate – ReWalk™

Device Description: 

  • Wearable powered exoskeleton
  • Snap‐together components-lumbar/hip, right & left upper leg, right & left lower leg
  • Hip component houses rechargeable battery pack, central processor, Bluetooth
  • Upper leg component houses two motors, embedded sensors and controllers
  • Microprocessors receive sensor signals on posture and tilt to control motion
  • Visual cues (LED lights)  and vibratory feedback inform therapist and patient
  • Indego controls self‐contained, crutches or walker used solely for stability
  • Users can  sit‐to‐stand and stand‐to‐sit, walk along even or uneven terrain
  • Physical therapist can configure, operate, monitor device via wireless application
  • Via Bluetooth connection,  gait speed and step length/height can be modified
  • Utilized in multiple indoor and outdoor locations within rehab/personal setting

Effectiveness:

  • Clinical study (n=40)  for assessing the mobility of persons with Spinal Cord Injury (SCI), 27 study sessions
  • Timed Up‐and‐Go (TUG) Test : 39 subjects completed with minimal assistance
  • Walking speed (Ten Meter Walk Test) :  0.38 m/s ± 0.08 m/s
  • Sustained walking: 38 subjects completed single‐session walk of 600 m
  • Level of assistance:  All subjects capable of managing all tested terrains
    and scenarios
  • Subject effort for basic level‐ground walking: “very light exercise”, “light exercise”

Safety:

  • Minor instances of bruising, redness, abrasion, swelling; attributed to improper fitting or improper padding
  • No Unanticipated Adverse Events (UAE).

 

 

 

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