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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 K881470
Device Name SOKEN PLUS(TM) ELECTRONIC MUSCLE STIMULATOR
Applicant
Rehab Medical Specialties, Inc.
1906 Silver St.
Garland,  TX  75042
Applicant Contact WILLIAM M BRANTMAN
Correspondent
Rehab Medical Specialties, Inc.
1906 Silver St.
Garland,  TX  75042
Correspondent Contact WILLIAM M BRANTMAN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/07/1988
Decision Date 03/10/1989
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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