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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K926136
Device Name WATSYSTEM
Applicant
Watsystem Div. of Itc
2425 S. Main
P.O. Box 241
Bloomington,  IL  61702
Applicant Contact BRUCE E HELLING
Correspondent
Watsystem Div. of Itc
2425 S. Main
P.O. Box 241
Bloomington,  IL  61702
Correspondent Contact BRUCE E HELLING
Regulation Number890.5380
Classification Product Code
BXB  
Date Received12/07/1992
Decision Date 05/20/1994
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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