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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K102837
Device Name HIROLLER ELEVATING WHEELCHAIR
Applicant
Max Mobility, LLC
5425 Mount View Pkwy.
Antioch,  TN  37013
Applicant Contact WILLIAM M RICHTER
Correspondent
Max Mobility, LLC
5425 Mount View Pkwy.
Antioch,  TN  37013
Correspondent Contact WILLIAM M RICHTER
Regulation Number890.3900
Classification Product Code
IPL  
Date Received09/29/2010
Decision Date 12/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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