FDA 510(k) Application Details - K061166

Device Classification Name	Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief   More FDA Info for this Device
510(K) Number	K061166
Device Name	Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief
Applicant	BIOWAVE CORPORATION 49 PLAIN STREET NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	MARY MCNAMARA-CULLINANE Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2006
Decision Date	08/15/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review