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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 K851037
Device Name ORTHOTRON MUSCLE STIMULATOR MK II DC
Applicant
Hodgkinson & Corby , Ltd.
Raymar
P.O. Box 16
Henley-On-Thames/England,  GB RG9 ILL
Applicant Contact RAYMOND HODGKINSON
Correspondent
Hodgkinson & Corby , Ltd.
Raymar
P.O. Box 16
Henley-On-Thames/England,  GB RG9 ILL
Correspondent Contact RAYMOND HODGKINSON
Regulation Number890.5850
Classification Product Code
IPF  
Date Received03/14/1985
Decision Date 06/19/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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