FDA gives J&J’s 510k clearance
August 19 , 2003
WASHINGTON - The FDA granted 510k clearance last week to Johnson & Johnson’s stair-climbing power wheelchair, the Independence iBot. The iBOT will cost about $29,000.
In addition to climbing stairs, small gyroscopes allow the iBOT to balance on two wheels to allow users elevate themselves to a standing position. Wheelchair users must weigh 250 pounds or less and have the use of one arm to operate the control panel to qualify for iBOT.
About 70% of the estimated two million wheelchair users in the United States could qualify for iBOT, say J&J officials.
J&J subsidiary Independence Technology, which will market iBOT, must submit to the FDA periodic reports on the effectiveness of the iBOT, as well as reports of user injuries, for the first two years. In an 18-person clinical trial of iBOT, three participants fell from the wheelchair, and two experienced bruises.
Critics content that at $29,000 the iBot will be a tough sell. But Jean-Luc Butel, president of Independence Technology, said the iBot’s price is less than the price of some specialized wheelchairs. The iBOT also will save users thousands of dollars that they would have to spend to modify their homes with ramps, elevators and other accommodations, Butel said.
A J&J spokesperson said that sales of iBOT would begin by the end of the year. Independence Technology officials said that the company has entered negotiations with Medicare and other health insurers about coverage for iBOT but did not comment on the progress of the negotiations, according to the Associated Press.