510(k) K052289

DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE by Biowave Corporation — Product Code LIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2005
Date Received
August 23, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interferential Current Therapy
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type