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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 K123972
Device Name WALKAIDE SYSTEM
Applicant
INNOVATIVE NEUROTRONICS INC.
3600-B N. CAPITAL OF TEXAS HWY
SUITE 150
AUSTIN,  TX  78746 -3211
Applicant Contact GLEN NEALLY
Correspondent
INNOVATIVE NEUROTRONICS INC.
3600-B N. CAPITAL OF TEXAS HWY
SUITE 150
AUSTIN,  TX  78746 -3211
Correspondent Contact GLEN NEALLY
Regulation Number882.5810
Classification Product Code
GZI  
Date Received12/26/2012
Decision Date 04/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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