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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K872974
Device Name DYNATRAC
Applicant
Med*Ex Diagnostics of Canada, Inc.
51 Leeder Ave.
Coquitlam,  CA
Applicant Contact MARK A KALICIAK
Correspondent
Med*Ex Diagnostics of Canada, Inc.
51 Leeder Ave.
Coquitlam,  CA
Correspondent Contact MARK A KALICIAK
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/30/1987
Decision Date 11/23/1987
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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