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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interactive Rehabilitation Exercise Devices
510(k) Number K923033
Device Name THE TRACKER
Applicant
EPM INFORMATION SYSTEMS, INC.
5212 HIGHBERRY WOODS RD.
MIDLOTHIAN,  VA  23112
Applicant Contact STEPHEN A BURTON
Correspondent
EPM INFORMATION SYSTEMS, INC.
5212 HIGHBERRY WOODS RD.
MIDLOTHIAN,  VA  23112
Correspondent Contact STEPHEN A BURTON
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received03/23/1992
Decision Date 06/01/1993
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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