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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 K151199
Device Name SmartDrive Wheelchair Power Assist
Applicant
MAX MOBILITY, LLC
5425 Crossings Blvd.
Antioch,  TN  37013
Applicant Contact Ben Hemkens
Correspondent
THIRD PARTY REVIEW GROUP, LLC
45 ROCKEFELLER PLAZA
SUITE 2000
NEW YORK,  NY  10111
Correspondent Contact DAVE YUNGVIRT
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/05/2015
Decision Date 07/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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