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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 K924545
Device Name MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR
Applicant
Mod Mode Medical
73 Broadmoor Cir.
Ormond Beach,  FL  32174
Applicant Contact JOHN MILOVICH
Correspondent
Mod Mode Medical
73 Broadmoor Cir.
Ormond Beach,  FL  32174
Correspondent Contact JOHN MILOVICH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/08/1992
Decision Date 12/01/1992
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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