510(k) K970131

ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE by C.L. Mcintosh & Assoc., Inc. — Product Code IMI

K970131 is an FDA 510(k) premarket notification submitted by C.L. Mcintosh & Assoc., Inc. for the device "ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE". The FDA issued a decision of Substantially Equivalent on June 16, 1997. 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. C.L. Mcintosh & Assoc., Inc. has at least 3 other 510(k) clearances on record.