510(k) K001860

PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA by Homedics, Inc. — Product Code IMC

K001860 is an FDA 510(k) premarket notification submitted by Homedics, Inc. for the device "PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA". The FDA issued a decision of Substantially Equivalent on August 10, 2000. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110. Homedics, Inc. has at least 1 other 510(k) clearance on record.