510(k) K041714

E-PAIN CARE by Breg, Inc. — Product Code FRN

K041714 is an FDA 510(k) premarket notification submitted by Breg, Inc. for the device "E-PAIN CARE". The FDA issued a decision of Substantially Equivalent on October 1, 2004. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Breg, Inc. has at least 10 other 510(k) clearances on record.