510(k) K162946

8ch Knee-Foot SPEEDER by Quality Electrodynamics, LLC — Product Code MOS

K162946 is an FDA 510(k) premarket notification submitted by Quality Electrodynamics, LLC for the device "8ch Knee-Foot SPEEDER". The FDA issued a decision of Substantially Equivalent on January 6, 2017. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Quality Electrodynamics, LLC has at least 10 other 510(k) clearances on record.