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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K954737
Device Name SURFACE ELECTROMYOGRAPH BIOFEEDBACK MUSCLE ACTIVITY DEVICE
Applicant
J-TECH, INC.
50 WEST CANYON RD.
ALPINE,  UT  84004
Applicant Contact TRACY LIVINGSTON
Correspondent
J-TECH, INC.
50 WEST CANYON RD.
ALPINE,  UT  84004
Correspondent Contact TRACY LIVINGSTON
Regulation Number882.5050
Classification Product Code
HCC  
Date Received10/16/1995
Decision Date 07/03/1996
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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