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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 K120405
Device Name WALK ON WHEELS HS-3500 ELECTRIC AISLE WHEELCHAIR
Applicant
WALK ON WHEELS AUSTRALIA PTY LTD
927 throne dr.
eugene,  OR  97402
Applicant Contact sheila ramerman
Correspondent
WALK ON WHEELS AUSTRALIA PTY LTD
927 throne dr.
eugene,  OR  97402
Correspondent Contact sheila ramerman
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/09/2012
Decision Date 09/19/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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