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510(k) K153224

VitalStim(R) Plus Electrotherapy System by Djo, LLC — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2016
Date Received
November 6, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

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