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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 K160031
Device Name Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)
Applicant
Sunrise Medical (Us), LLC
2842 Business Park Av
Fresno,  CA  93727
Applicant Contact LAURIE H ROBERTS
Correspondent
Sunrise Medical (Us), LLC
2842 Business Park Av
Fresno,  CA  93727
Correspondent Contact LAURIE H ROBERTS
Regulation Number890.3860
Classification Product Code
ITI  
Date Received01/07/2016
Decision Date 07/14/2016
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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