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)