510(k) K163308

SMARTO by Jeil Medical Corporation — Product Code KIJ

K163308 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "SMARTO". The FDA issued a decision of Substantially Equivalent on December 27, 2016. The device falls under product code KIJ (Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Jeil Medical Corporation has at least 10 other 510(k) clearances on record.