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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 K891118
Device Name STERLING TENS
Applicant
Armstrong Industries, Inc.
1202 Richardson Dr. Suite 309
Richardson,  TX  75080
Applicant Contact BECKY HORN
Correspondent
Armstrong Industries, Inc.
1202 Richardson Dr. Suite 309
Richardson,  TX  75080
Correspondent Contact BECKY HORN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/02/1989
Decision Date 09/06/1989
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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