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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 K182946
Device Name Invacare TDX SP2-HD with Captain's Seat
Applicant
Invacare Corporation
One Invacare Way
Elyria,  OH  44035
Applicant Contact Elijah Wreh
Correspondent
Invacare Corporation
One Invacare Way
Elyria,  OH  44035
Correspondent Contact Elijah Wreh
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/23/2018
Decision Date 12/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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