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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K030800
Device Name ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
Applicant
Eletromed, Inc.
4938 Hamden Ln. #750
Betheda,  MD  20814
Applicant Contact LYDIA BAYNES
Correspondent
Eletromed, Inc.
4938 Hamden Ln. #750
Betheda,  MD  20814
Correspondent Contact LYDIA BAYNES
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/13/2003
Decision Date 06/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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