LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE


Device Classification Name

stimulator, electrical, non-implantable, for incontinence

510(k) Number K122194
Device Name LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3 fl., no. 5, lane 155, sec.3,
peishen rd.
shen keng hsiang,taipei hsien, 

TW

222

Applicant Contact robert tu
Correspondent
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3 fl., no. 5, lane 155, sec.3,
peishen rd.
shen keng hsiang,taipei hsien, 

TW

222

Correspodent Contact robert tu
Regulation Number 876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received 07/24/2012
Decision Date 04/04/2013
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

Category: Uncategorized