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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 K895760
Device Name ELECTRICAL MUSCLE STIMULATOR--PGS 2000 TENS DEVICE
Applicant
Universal Technology Systems, Inc.
P.O. Box 7908
Jacksonville,  FL  32238
Applicant Contact THOMAS J MCENANY
Correspondent
Universal Technology Systems, Inc.
P.O. Box 7908
Jacksonville,  FL  32238
Correspondent Contact THOMAS J MCENANY
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/26/1989
Decision Date 01/02/1990
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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