Food and Drug Administration
Orthopaedic and Rehabilitation Devices Panel
November 20, 2002
Briefing Information
Independence™ IBOT™ 3000 Mobility System
Disclaimer
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Team Leader Overview, Robert DeLuca, FDA (Word) (PDF)
Engineering Review Summary (Word) (PDF)
Memorandum Containing the Review of P020033 for the Independence™ IBOT™ 3000 Mobility System, Marie Schroeder, MS, PT (Word) (PDF)
Summary of Statistical Review Findings (Word) (PDF)
Human Factors and Patient Labeling Review (Word) (PDF)
Software Review, Joseph Jorgens III, (Word) (PDF)
Summary of Electromagnetic Compatibility Testing (Word) (PDF)
Summary of Data Information Contained in the PMA (Word) (PDF)