510(k) K112148

POWERED MUSCLE STIMULATOR by Valmed, SA — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2012
Date Received
July 27, 2011
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