This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: INDEPENDENCE™ iBOT™ 3000 Mobility System
Manufacturer: Independence Technology, L.L.C.
Address: 45 Technology Drive, Warren, New Jersey 07059
Approval Date: August 13, 2003
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020033a.pdf
What is it? The INDEPENDENCE™ iBOT™ 3000 Mobility System is a new indoor/outdoor power mobility device that can rise to eye level, drive over uneven surfaces, climb curbs, and go up or down stairs. Because of its unique balancing mechanism, the device remains stable and the seat stays level under most conditions.
How does it work? The iBOT™ has five operating functions:
- Standard (for driving indoors and across smooth surfaces)
- 4-Wheel (for driving over uneven surfaces such as curbs, grass, or gravel)
- Balance (for rising to eye level or reaching objects at an elevated height)
- Stair (for climbing up and down stairs
- Remote (for transporting the device while unoccupied)
In Standard function, the iBOT™ works like other power wheelchairs. In the other functions, the device uses computers, gyroscopes, and electric motors to provide stability and balance. In these functions, the gyroscopes constantly measure stability. When the gyroscopes sense movement, they signal the computer. The computer then drives the motors to move the wheels so that the device remains upright and stable.
The iBOT™ has two pairs of rear drive wheels. In Balance function, the iBOT™ lifts one pair of wheels off the ground and balances on the remaining pair of wheels. In Stair function, the drive wheels rotate up and over each other to climb up or down, one stair at a time.
When is it used? The iBOT™ can be used indoors or outdoors by people with mobility impairments and the use of at least one upper extremity. It is available by prescription only, from specially trained health professionals.
What will it accomplish? The INDEPENDENCE™ iBOT™ 3000 Mobility System provides:
- mobility on smooth surfaces and inclines at home and in the community
- movement over obstacles, uneven terrain, curbs, grass, gravel, and other soft surfaces
- mobility in a seated position at an elevated height
- ascent or descent of stairs with or without assistance
- transport of the unoccupied product
When should it not be used? This device should not be used until an individual has completed a training program. In addition, it should not be used by individuals who:
- weigh more than 250 pounds
- cannot use at least one hand
- cannot bend their knees enough to use standard footrests
- require tilt or recline seating systems
- need mechanical ventilators
- have conditions that increase their risk of bone fractures (severe osteoporosis, osteogenesis imperfecta, or metastatic bone cancer)
Additional Information: The Summary of Safety and Effectiveness Data and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P020033