summaryofdatainformationcontainedinthepma.docVIP

Summary of Data Information Contained in the PMA Summary Information This summary contains the following information: General Information Indications for Use Contraindications Warnings Precautions Device Description Alternative Practices and Procedures Marketing History Adverse Events Summary of Studies Nonclinical Studies Clinical Investigations Conclusions Drawn from Studies Panel Recommendation CDRH Decision Approval Specification 1. General Information Device Generic Name Advanced Mobility System Device Trade Name INDEPENDENCE? iBOT? 3000 Mobility System Applicant’s Name and Address Independence Technology, LLC. 45 Technology Drive Warren, NJ 07059 PMA Number P020033 Date of Panel Recommendation 11/20/02 Date of Notice of Approval to Applicant TBD 2. Indications For Use The INDEPENDENCE? iBOT? 3000 Mobility System is a powered mobility device for individuals who have mobility impairments and the use of at least one upper extremity. The device is intended to provide indoor and outdoor mobility in confined spaces, at an elevated height, climb curbs, ascend/descend stairs, traverse obstacles, travel over a wide variety of terrain and negotiate uneven/inclined surfaces.  3. Contra-indications Contraindications are the Inclusion/Exclusion criteria presented in the product labeling. 4. Warnings Fracture risks for persons with severe osteopenia, osteogenesis imperfecta and spinal metastatic bone cancer. Additional Warnings regarding proper use are presented throughout the product labeling. 5. Precautions Complete training Read product labeling thoroughly. Additional Precautions are presented throughout product labeling. 6. Device Description The INDEPENDENCE? iBOT? 3000 Mobility System is a battery operated advanced mobility system designed for both indoor and outdoor use. The INDEPENDENCE? iBOT? 3000 Mobility System can be divided into two essential parts – a Seating System and a Power Base. The seating system includes all the