510(k) K010702

XUB EXTERNAL ULTRASOUND by Kmi Kolster Methods, Inc. — Product Code IMI

K010702 is an FDA 510(k) premarket notification submitted by Kmi Kolster Methods, Inc. for the device "XUB EXTERNAL ULTRASOUND". The FDA issued a decision of Substantially Equivalent on August 9, 2001. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Kmi Kolster Methods, Inc. has at least 5 other 510(k) clearances on record.