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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 K000174
Device Name ACTION AF-1 WHEELCHAIR
Applicant
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036 -2125
Applicant Contact EDWARD A KROLL
Correspondent
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036 -2125
Correspondent Contact EDWARD A KROLL
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/20/2000
Decision Date 02/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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