510(k) K964526

LIBERTY RECTAL PELVIC FLOOR EXERCISER by Utah Medical Products, Inc. — Product Code KPI

K964526 is an FDA 510(k) premarket notification submitted by Utah Medical Products, Inc. for the device "LIBERTY RECTAL PELVIC FLOOR EXERCISER". The FDA issued a decision of Substantially Equivalent on February 10, 1997. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Utah Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1997
Date Received
November 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Device Class
Class II
Regulation Number
876.5320
Review Panel
GU
Submission Type