510(k) K862410

MILEX KEGEL PERINEAL EXERCISER by Milex Products, Inc. — Product Code HIR

K862410 is an FDA 510(k) premarket notification submitted by Milex Products, Inc. for the device "MILEX KEGEL PERINEAL EXERCISER". The FDA issued a decision of Substantially Equivalent on July 31, 1986. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Milex Products, Inc. has at least 7 other 510(k) clearances on record.