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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, powered
510(k) Number K113488
Device Name JAZZY ELITE 6
Original Applicant
182 susquehanna ave.
exeter,  PA  18643
Original Contact kimberly blake
Regulation Number890.3860
Classification Product Code
Date Received11/23/2011
Decision Date 04/18/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No