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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 K864010
Device Name EMPI MODEL 712, LOGIX(TM), NMS
Applicant
Empi
261 S. Commerce Cir.
Minneapolis,  MN  55432
Applicant Contact MIRIAM J GOLDBERG
Correspondent
Empi
261 S. Commerce Cir.
Minneapolis,  MN  55432
Correspondent Contact MIRIAM J GOLDBERG
Regulation Number890.5850
Classification Product Code
IPF  
Date Received10/15/1986
Decision Date 12/02/1986
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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