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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 K123642
Device Name MUSCLE STIMULATION SYSTEM
Applicant
Niveus Medical, Inc.
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Applicant Contact CINDY DOMECUS, R.A.C. (US & EU)
Correspondent
Niveus Medical, Inc.
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Correspondent Contact CINDY DOMECUS, R.A.C. (US & EU)
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/26/2012
Decision Date 03/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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