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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 K192216
Device Name Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
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 Received08/15/2019
Decision Date 01/02/2020
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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