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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 K202379
Device Name Invacare AVIVA Storm RX Power Chair
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 Received08/20/2020
Decision Date 03/19/2021
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
Recalls CDRH Recalls
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