FDA 510(k) Application Details - K040512

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K040512
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	WELL-LIFE HEALTHCARE, INC. 1109 MYATT BLVD. MADISON, TN 37115 US Other 510(k) Applications for this Company
Contact	MIKE PRICE Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	GZJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2004
Decision Date	05/27/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review