510(k) Report

Devices descending from K120628

4 later devices reach HELIO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260295Helio Kids; Apex PMotion Composites20260—
+1K161425APEX Manual WheelchairMotion Composites20163—
+2K243111Bowhead ERA WheelchairsBowhead Design Corp.20251—
+3K260121Manual Wheelchair (7101L, 7102LHD)Foshan Nanhai Hongchen Medical Equipment Co., Ltd.20260—