510(k) K121702

ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE by Orthocor Medical — Product Code ILX

K121702 is an FDA 510(k) premarket notification submitted by Orthocor Medical for the device "ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE". The FDA issued a decision of Substantially Equivalent on May 6, 2013. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Orthocor Medical has at least 2 other 510(k) clearances on record.