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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, mechanical
510(k) Number K120628
Device Name HELIO
Original Applicant
519 j-oswald-forest
suite 101
saint-roch-de-l' achigan,  CA j063h0
Original Contact vincent lecuyer
Regulation Number890.3850
Classification Product Code
Date Received03/01/2012
Decision Date 12/19/2012
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