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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 K874076
Device Name MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR
Applicant
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Applicant Contact J. C CASTEL
Correspondent
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Correspondent Contact J. C CASTEL
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/06/1987
Decision Date 01/04/1988
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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