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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Warning, Overload, External Limb, Powered
510(k) Number K960307
Device Name INDEX SHOE
Applicant
Orthopedic Technology Research, Inc.
819 W. Stryker Ave.
Suite 10
Sacramento,  CA  95834
Applicant Contact BRIAN T CLEARY
Correspondent
Orthopedic Technology Research, Inc.
819 W. Stryker Ave.
Suite 10
Sacramento,  CA  95834
Correspondent Contact BRIAN T CLEARY
Regulation Number890.5575
Classification Product Code
IRN  
Date Received01/22/1996
Decision Date 06/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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