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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 K023589
Device Name STORM TDX POWER WHEELCHAIR
Applicant
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036 -2125
Applicant Contact RAE ANN FARROW
Correspondent
INVACARE CORP.
ONE INVACARE WAY
P.O. BOX 4028
ELYRIA,  OH  44036 -2125
Correspondent Contact RAE ANN FARROW
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/25/2002
Decision Date 11/19/2002
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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