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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 K946230
Device Name ENDURA REUSABLE TENS AND NMES ELECTRODES
Applicant
Selectivemed Components, Inc.
208 W. High St.
Mt. Vernon,  OH  43050
Applicant Contact RICHARD J FISHER, JR.
Correspondent
Selectivemed Components, Inc.
208 W. High St.
Mt. Vernon,  OH  43050
Correspondent Contact RICHARD J FISHER, JR.
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/22/1994
Decision Date 12/22/1995
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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