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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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