KEGEL8 PELVIC EXERCISER, MODEL OPH 400


Device Classification Name

stimulator, electrical, non-implantable, for incontinence

510(k) Number K081480
Device Name KEGEL8 PELVIC EXERCISER, MODEL OPH 400
Applicant
NE SERVICES LTD.
4663 kate lane
oxford, 
OH 
45056

Applicant Contact brent reider
Correspondent
NE SERVICES LTD.
4663 kate lane
oxford, 
OH 
45056

Correspodent Contact brent reider
Regulation Number 876.5320
Classification Product Code
KPI  
Date Received 05/27/2008
Decision Date 09/12/2008
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