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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 K865072
Device Name ARROW XT POWERED WHEELCHAIR
Applicant
Ivacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact JAMES R THALER
Correspondent
Ivacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact JAMES R THALER
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/29/1986
Decision Date 01/21/1987
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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