510(k) K124016

EMPI PHOENIX by Djo, LLC — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2013
Date Received
December 27, 2012
Clearance Type
Abbreviated
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