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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 K112348
Device Name RS-4I MUSCLE STIMULATOR
Applicant
Rs Medical
14401 SE First St.
Vancouver,  WA  98684
Applicant Contact PATRICK COUGILL
Correspondent
Rs Medical
14401 SE First St.
Vancouver,  WA  98684
Correspondent Contact PATRICK COUGILL
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
LIH  
Date Received08/16/2011
Decision Date 01/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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