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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 K982482
Device Name HANDMASTER NMS1
Applicant
N.E.S.S. Nuromuscular Electrical Stimulation Syst
555 Thirteenth St. NW
Columbia Square
Washington,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
N.E.S.S. Nuromuscular Electrical Stimulation Syst
555 Thirteenth St. NW
Columbia Square
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/16/1998
Decision Date 09/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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