FDA 510(k) Application Details - K003258

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K003258
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	HOME WELLNESS WEST 9393 ACTIVITY RD. SUITE F SAN DIEGO, CA 92126 US Other 510(k) Applications for this Company
Contact	C.A. TEKLINSKI 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	10/18/2000
Decision Date	01/12/2001
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