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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 K031900
Device Name HANDMASTER
Applicant
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
555 13TH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Applicant Contact JONATHAN KAHAN
Correspondent
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
555 13TH STREET, N.W.
WASHINGTON,  DC  20004 -1109
Correspondent Contact JONATHAN KAHAN
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received06/19/2003
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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