510(k) K132284

VECTRA NEO CLINICAL THERAPY SYSTEM by Djo, LLC — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2014
Date Received
July 23, 2013
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