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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 K954272
Device Name INNOVA RECTAL STIMULATON ELECTRODE
Applicant
Empi
5255 E. River Rd.
Minneapolis,  MN  55421
Applicant Contact STACY MATTSON
Correspondent
Empi
5255 E. River Rd.
Minneapolis,  MN  55421
Correspondent Contact STACY MATTSON
Regulation Number876.5320
Classification Product Code
KPI  
Date Received09/12/1995
Decision Date 04/15/1996
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
Predetermined Change
Control Plan Authorized		 No
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