510(k) K163451

Action Trackstander models TR1816, TR1820, TR2016, and TR2020 by Action Manufacturing, Inc. — Product Code IPL

K163451 is an FDA 510(k) premarket notification submitted by Action Manufacturing, Inc. for the device "Action Trackstander models TR1816, TR1820, TR2016, and TR2020". The FDA issued a decision of Substantially Equivalent on January 12, 2018. The device falls under product code IPL (Wheelchair, Standup), a Class II device regulated under 21 CFR 890.3900. Action Manufacturing, Inc. has at least 2 other 510(k) clearances on record.