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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 K932399
Device Name THERAPEUTIC STIM 200 (TS-200)/200P (TS-200P)
Applicant
Myo/Kinetic Systems, Inc.
N84 W13562 Leon Rd.
Menomonee Falls,  WI  53051
Applicant Contact HASSAN HAMEDI
Correspondent
Myo/Kinetic Systems, Inc.
N84 W13562 Leon Rd.
Menomonee Falls,  WI  53051
Correspondent Contact HASSAN HAMEDI
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/18/1993
Decision Date 08/11/1993
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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