Home / 510(k) Clearances / K170132

510(k) K170132

MyoCycle Home, MyoCycle Pro by Myolyn, LLC — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2017
Date Received
January 17, 2017
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

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