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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 K843964
Device Name TENS-AID PREMIUM ELECTRODES
Applicant
Staodynamics, Inc.
1225 Florida Ave.
P.O. Box 1379
Longmont,  CO  80502
Applicant Contact SAMUELLA EMRICH
Correspondent
Staodynamics, Inc.
1225 Florida Ave.
P.O. Box 1379
Longmont,  CO  80502
Correspondent Contact SAMUELLA EMRICH
Regulation Number882.1320
Classification Product Code
GXY  
Date Received10/11/1984
Decision Date 02/25/1985
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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