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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 K083249
Device Name QUICKIE RHYTHM
Applicant
Sunrise Medical Hhg, Inc.
7477 E. Dry Creek Pkwy.
Longmont,  CO  80503
Applicant Contact JAMES W LEWIS
Correspondent
Sunrise Medical Hhg, Inc.
7477 E. Dry Creek Pkwy.
Longmont,  CO  80503
Correspondent Contact JAMES W LEWIS
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/04/2008
Decision Date 12/23/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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