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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Isokinetic Testing And Evaluation
510(k) Number K875235
Device Name ISOKINETIC SYSTEM, TESTING AND EVALUATION
Applicant
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Applicant Contact ROBERT MOORE
Correspondent
Orthopedic Systems, Inc.
1897 National Ave.
Hayward,  CA  94545
Correspondent Contact ROBERT MOORE
Regulation Number890.1925
Classification Product Code
IKK  
Date Received12/22/1987
Decision Date 01/19/1988
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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