FDA 510(k) Application Details - K041063

Device Classification Name	Stimulator, Muscle, Powered   More FDA Info for this Device
510(K) Number	K041063
Device Name	Stimulator, Muscle, Powered
Applicant	NEWWAVE MEDICAL LLC 620 HAGGARD STREET STE. 614 PLANO, TX 75074 US Other 510(k) Applications for this Company
Contact	ROBERT ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	890.5850   More FDA Info for this Regulation Number
Classification Product Code	IPF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2004
Decision Date	12/01/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review