510(k) K013612

INCARE PELVIC FLOOR THERAPY SYSTEM by Hollister, Inc. — Product Code HIR

K013612 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "INCARE PELVIC FLOOR THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 19, 2002. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Hollister, Inc. has at least 10 other 510(k) clearances on record.