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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 K213925
Device Name MyoCycle MC-2 (Home / Home + / Pro / Pro +)
Applicant
Myolyn, LLC
6931 NW 22nd St., Suite A
Gainesville,  FL  32653 -1231
Applicant Contact Matthew Bellman
Correspondent
Myolyn, LLC
6931 NW 22nd St., Suite A
Gainesville,  FL  32653 -1231
Correspondent Contact Matthew Bellman
Regulation Number882.5810
Classification Product Code
GZI  
Date Received12/16/2021
Decision Date 04/25/2022
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
Recalls CDRH Recalls
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