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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K901586
Device Name TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER
Applicant
Invacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact JAMES R THALER
Correspondent
Invacare Corp.
899 Cleveland St.
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact JAMES R THALER
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/04/1990
Decision Date 04/16/1990
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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