PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM


Device Classification Name

stimulator, electrical, non-implantable, for incontinence

510(k) Number K023906
Device Name PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
Original Applicant
THE PROMETHEUS GROUP
1 washington st., suite 303
dover, 
NH 
03820

Original Contact heather magoon
Regulation Number 876.5320
Classification Product Code
KPI  
Date Received 11/22/2002
Decision Date 02/19/2003
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