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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K882386
Device Name AGAR 3K NEUROMUSCULAR STIMULATOR
Applicant
Solcoor, Inc.
8150 Leesburg Pike, Suite 700
Vienna,  VA  22180
Applicant Contact BARBARA A MARSDEN
Correspondent
Solcoor, Inc.
8150 Leesburg Pike, Suite 700
Vienna,  VA  22180
Correspondent Contact BARBARA A MARSDEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/10/1988
Decision Date 10/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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