510(k) K944596

GRAHAM-FIELD ULTRASOUND LOTION by Chester Labs, Inc. — Product Code IMI

K944596 is an FDA 510(k) premarket notification submitted by Chester Labs, Inc. for the device "GRAHAM-FIELD ULTRASOUND LOTION". The FDA issued a decision of Substantially Equivalent on June 7, 1995. 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. Chester Labs, Inc. has at least 10 other 510(k) clearances on record.