ATHENA PELVIC MUSCLE TRAINER


Device Classification Name

stimulator, electrical, non-implantable, for incontinence

510(k) Number K023905
Device Name ATHENA PELVIC MUSCLE TRAINER
Original Applicant
ATHENA FEMININE TECHNOLOGIES, INC.
179 moraga way
orinda, 
CA 
92520

Original Contact barbara sarkis
Regulation Number 876.5320
Classification Product Code
KPI  
Date Received 11/22/2002
Decision Date 04/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No