510(k) K974048

INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER by Hollister, Inc. — Product Code KPI

K974048 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER". The FDA issued a decision of Substantially Equivalent on December 23, 1997. The device falls under product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence), a Class II device regulated under 21 CFR 876.5320. Hollister, Inc. has at least 10 other 510(k) clearances on record.