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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K890695
Device Name HI-RIDER WHEELCHAIR
Applicant
Retec USA, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Applicant Contact FRANK J KOPFER
Correspondent
Retec USA, Inc.
10 Centre Dr.
Orchard Park,  NY  14127
Correspondent Contact FRANK J KOPFER
Regulation Number890.3900
Classification Product Code
IPL  
Date Received02/10/1989
Decision Date 04/10/1989
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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