510(k) K132284

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

K132284 is an FDA 510(k) premarket notification submitted by Djo, LLC for the device "VECTRA NEO CLINICAL THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 10, 2014. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Djo, LLC has at least 10 other 510(k) clearances on record.

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