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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 K142457
Device Name Quickie, Zippie
Applicant
Sunrise Medical (Us), LLC
2842 Business Park Ave.
Fresno,  CA  93727
Applicant Contact Laurie Roberts
Correspondent
Sunrise Medical (Us), LLC
2842 Business Park Ave.
Fresno,  CA  93727
Correspondent Contact Laurie Roberts
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/02/2014
Decision Date 12/18/2014
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
Recalls CDRH Recalls
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