510(k) K161502

MC1 Plus by General Project S.R.L. — Product Code IMI

K161502 is an FDA 510(k) premarket notification submitted by General Project S.R.L. for the device "MC1 Plus". The FDA issued a decision of Substantially Equivalent on August 16, 2016. 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. General Project S.R.L. has at least 5 other 510(k) clearances on record.