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
|
|
Correspondent Contact |
ROBERT TU |
Regulation Number | 876.5320
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|