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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K060669
Device Name MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300
Applicant
HEALTHONICS, INC.
903 MAIN ST. SOUTH
NEW ELLENTON,  SC  29809
Applicant Contact JAMES W KRONBERG
Correspondent
HEALTHONICS, INC.
903 MAIN ST. SOUTH
NEW ELLENTON,  SC  29809
Correspondent Contact JAMES W KRONBERG
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
NYN  
Date Received03/14/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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