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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 K850004
Device Name TRANSCUTANEOUS NERVE STIMULATOR FOR PAIN RELIEF
Applicant
Todd Medical, Inc.
7755 Freedom Ave. NW
N Canton,  OH  44720
Applicant Contact MICHAEL SCAGLIONE
Correspondent
Todd Medical, Inc.
7755 Freedom Ave. NW
N Canton,  OH  44720
Correspondent Contact MICHAEL SCAGLIONE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/02/1985
Decision Date 04/02/1985
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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