DevicePMAs@therightstef:P020033_S002 / 260-265
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Approval for generational changes to the approved device. The device, as modified, will be marketed under the trade name independence ibot 4000 mobility system. The device is indicated for individuals who have mobility impairments and the use of at least on upper extremity. The device is intended to provide mobility on smooth surfaces and inclines at home, at work ,and in other environments; movement across obstacles, uneven terrain, curbs, grass, gravel and other soft surfaces; mobility in a seated position at an elevated height; ascent and decent of stairs with or without assistance; and mobility and transportation.
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