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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 K895633
Device Name MYOTRACE 10 BIOFEEDBACK DEVICE
Applicant
Noraxon USA, Inc.
8381 E. Gelding Rd.
Scottsdale,  AZ  85260
Applicant Contact SIPILA, MD
Correspondent
Noraxon USA, Inc.
8381 E. Gelding Rd.
Scottsdale,  AZ  85260
Correspondent Contact SIPILA, MD
Regulation Number882.5050
Classification Product Code
HCC  
Date Received09/19/1989
Decision Date 04/13/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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