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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K012823
Device Name MODIFICATION TO HANDMASTER
Applicant
Ness-Neuromuscular Electrical Stimulation Systems
555 13th St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S HAHAN
Correspondent
Ness-Neuromuscular Electrical Stimulation Systems
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S HAHAN
Regulation Number882.5810
Classification Product Code
GZI  
Date Received08/16/2001
Decision Date 11/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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