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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 K941049
Device Name MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
Applicant
Smith & Nephew, Inc.
2777 Loker Ave., W.
Suite 100
Carlsbad,  CA  92008
Applicant Contact DAN W MILLER
Correspondent
Smith & Nephew, Inc.
2777 Loker Ave., W.
Suite 100
Carlsbad,  CA  92008
Correspondent Contact DAN W MILLER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/07/1994
Decision Date 05/19/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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