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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 K143383
Device Name Q6 Edge EM
Applicant
Pride Mobility Product Corporation
182 Susquehanna Ave.
Exeter,  PA  18643
Applicant Contact Kimberly Elmes
Correspondent
Pride Mobility Product Corporation
182 Susquehanna Ave.
Exeter,  PA  18643
Correspondent Contact Kimberly Elmes
Regulation Number890.3860
Classification Product Code
ITI  
Date Received11/25/2014
Decision Date 07/23/2015
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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