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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 K170132
Device Name MyoCycle Home, MyoCycle Pro
Applicant
Myolyn, LLC
7731 W. Newberry Rd., Suite A-2
Gainesville,  FL  32606
Applicant Contact Matthew Bellman
Correspondent
Myolyn, LLC
7731 W. Newberry Rd., Suite A-2
Gainesville,  FL  32606
Correspondent Contact Matthew Bellman
Regulation Number882.5810
Classification Product Code
GZI  
Date Received01/17/2017
Decision Date 04/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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