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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wheelchair, mechanical
510(k) Number K984447
Device Name MODEL ACTION AT II MANUAL WHEELCHAIR
Applicant
INVACARE CORP.
1200 TAYLOR ST.
ELYRIA,  OH  44036
Applicant Contact EDWARD A KROLL
Correspondent
INVACARE CORP.
1200 TAYLOR ST.
ELYRIA,  OH  44036
Correspondent Contact EDWARD A KROLL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/14/1998
Decision Date 01/08/1999
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
Recalls CDRH Recalls
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