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510(k) K213925

MyoCycle MC-2 (Home / Home + / Pro / Pro +) by Myolyn, LLC — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2022
Date Received
December 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Neuromuscular, External Functional
Device Class
Class II
Regulation Number
882.5810
Review Panel
NE
Submission Type

Other clearances by Myolyn, LLC

  • K170132 — MyoCycle Home, MyoCycle Pro (April 25, 2017)

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