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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 K993413
Device Name STORM SERIES, POWER 9000 SERIES AND POWER TIGER WITH GYROSCOPE CONTROL
Applicant
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact EDWAED A KROLL
Correspondent
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact EDWAED A KROLL
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/12/1999
Decision Date 12/15/1999
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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