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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 K153636
Device Name Liberator Powered Wheelchair with Solar Companion
Applicant
Solar Mobilityllc
1426 E. 3rd Ave.
Kennewick,  WA  99336
Applicant Contact KURT SCHNEIDER
Correspondent
Smith Associates
1468 Harwell Ave.,
Crofton,  MD  21114
Correspondent Contact E.J SMITH
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/18/2015
Decision Date 09/09/2016
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
Predetermined Change
Control Plan Authorized
No
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