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510(k) K141812

MYGAIT STIMULATION SYSTEM by Otto Bock Healthcare Products GmbH — Product Code GZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2015
Date Received
July 7, 2014
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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