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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received07/24/2012
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
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