510(k) K050701

THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 by Bionix Development Corp. — Product Code IYE

K050701 is an FDA 510(k) premarket notification submitted by Bionix Development Corp. for the device "THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010". The FDA issued a decision of Substantially Equivalent on April 1, 2005. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Bionix Development Corp. has at least 10 other 510(k) clearances on record.