TENSCARE ITOUCH SURE MODEL ITS


Device Classification Name

stimulator, electrical, non-implantable, for incontinence

510(k) Number K103698
Device Name TENSCARE ITOUCH SURE MODEL ITS
Applicant
TENSCARE LTD.
9 blenheim road
epsom, surrey, 

GB

kt19 9be

Applicant Contact andrew brown
Correspondent
TENSCARE LTD.
9 blenheim road
epsom, surrey, 

GB

kt19 9be

Correspodent Contact andrew brown
Regulation Number 876.5320
Classification Product Code
KPI  
Date Received 12/20/2010
Decision Date 06/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No