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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 K851331
Device Name EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)
Applicant
Empi
261 S. Commerce Cir.
Minneapolis,  MN  55432
Applicant Contact GEORGE E MATHIESEN
Correspondent
Empi
261 S. Commerce Cir.
Minneapolis,  MN  55432
Correspondent Contact GEORGE E MATHIESEN
Regulation Number890.5380
Classification Product Code
BXB  
Date Received04/04/1985
Decision Date 07/17/1985
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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