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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 K832145
Device Name MONOBLOCK PROSTOPERATIVE TENS ELECTRODE
Applicant
New Dimensions IN Medicine, Inc.
3040 E. River Rd.
P.O. Box 1408
Dayton,  OH  45401
Applicant Contact JOHN E SHUMWAY
Correspondent
New Dimensions IN Medicine, Inc.
3040 E. River Rd.
P.O. Box 1408
Dayton,  OH  45401
Correspondent Contact JOHN E SHUMWAY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/05/1983
Decision Date 07/19/1983
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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