510(k) Report

Devices descending from K161425

3 later devices reach APEX Manual Wheelchair through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260295Helio Kids; Apex PMotion Composites20260—
+1K243111Bowhead ERA WheelchairsBowhead Design Corp.20251—
+2K260121Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd.20260—