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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 K030998
Device Name MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300
Applicant
Healthonics, Inc.
903 Main St. S.
New Ellenton,  SC  29809
Applicant Contact JAMES W KRONBERG
Correspondent
Healthonics, Inc.
903 Main St. S.
New Ellenton,  SC  29809
Correspondent Contact JAMES W KRONBERG
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received03/31/2003
Decision Date 10/10/2003
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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