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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoe, Cast
510(k) Number K024279
Device Name NESS CHILDREN SYSTEM
Applicant
Ness-Neuromuscular Electrical Stimulation Systems
555 13th St., NW
Washington,  DC  20004
Applicant Contact JONATHAN S KAHAN
Correspondent
Ness-Neuromuscular Electrical Stimulation Systems
555 13th St., NW
Washington,  DC  20004
Correspondent Contact JONATHAN S KAHAN
Regulation Number890.3025
Classification Product Code
IPG  
Date Received12/23/2002
Decision Date 02/05/2003
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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