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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 K862454
Device Name AGAR 7K TENS INSTRUMENT
Applicant
Solcoor, Inc.
8150 Leesburg Pike, Suite 700
Vienna,  VA  22180
Applicant Contact BARBARA MARSDEN
Correspondent
Solcoor, Inc.
8150 Leesburg Pike, Suite 700
Vienna,  VA  22180
Correspondent Contact BARBARA MARSDEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/27/1986
Decision Date 03/25/1987
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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