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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 K852077
Device Name VERSA STIM 380, MUSCLE STIMULATOR
Applicant
Electro-Med Health Industries, Inc.
6240 NE Fourth Ct.
Miami,  FL  33138
Applicant Contact ALAN P SCHWARTZ
Correspondent
Electro-Med Health Industries, Inc.
6240 NE Fourth Ct.
Miami,  FL  33138
Correspondent Contact ALAN P SCHWARTZ
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/13/1985
Decision Date 08/21/1985
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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