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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 K882943
Device Name MEDA ONE-STEP
Applicant
Medical Electronic Assn.
8100 S. Akron, Suite 320
Englewood,  CO  80112
Applicant Contact DENNIS R MCGIMSEY
Correspondent
Medical Electronic Assn.
8100 S. Akron, Suite 320
Englewood,  CO  80112
Correspondent Contact DENNIS R MCGIMSEY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/11/1988
Decision Date 08/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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