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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 K850850
Device Name AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR
Applicant
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Applicant Contact JAMES G BAUMANN
Correspondent
Physio Technology, Inc.
1925 W. 6th St.
Topeka,  KS  66606
Correspondent Contact JAMES G BAUMANN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/01/1985
Decision Date 07/01/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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