FDA 510(k) Application Details - K011543

Device Classification Name	Stimulator, Nerve, Transcutaneous, For Pain Relief   More FDA Info for this Device
510(K) Number	K011543
Device Name	Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant	TENS CARE LTD. 76, STOCKPORT ROAD TIMPERLRY WA15 7SN GB Other 510(k) Applications for this Company
Contact	BERNARD JOHN TREMAINE 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	05/18/2001
Decision Date	08/31/2001
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