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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interferential Current Therapy
510(k) Number K921612
Device Name INTERTRON 4500, INTERTRON 5000, MASTERSTIM I-2
Applicant
Medstar, Inc.
601 N. Murlen, Suite 16
Olathe,  KS  66062
Applicant Contact CRAIG SEYL
Correspondent
Medstar, Inc.
601 N. Murlen, Suite 16
Olathe,  KS  66062
Correspondent Contact CRAIG SEYL
Regulation Number882.5890
Classification Product Code
LIH  
Date Received04/03/1992
Decision Date 08/18/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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