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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Goniometer, Ac-Powered
510(k) Number K971079
Device Name INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
Applicant
Interlogics, Inc.
P.O. Box 1239
Hillsborough,  NC  27278
Applicant Contact DONALD R MCINTYRE
Correspondent
Interlogics, Inc.
P.O. Box 1239
Hillsborough,  NC  27278
Correspondent Contact DONALD R MCINTYRE
Regulation Number888.1500
Classification Product Code
KQX  
Date Received03/25/1997
Decision Date 07/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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