# K161425: APEX Manual Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Motion Composites
- Decided: Dec 5, 2016 after 196 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K850536 (1985). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123975: Quickie & Zippie Series, Sunrise Medical (2013) Summary page 4.
- K120628: HELIO, Motion Composites (2012) Summary page 4.

## Most influential descendants
- K243111: Bowhead ERA Wheelchairs (2025), 1 descendant of its own
- K260295: Helio Kids; Apex P (2026), 0 descendants of its own
- K260121: Manual Wheelchair (7101L, 7102LHD) (2026), 0 descendants of its own

## Indications for use
The indications for use of the APEX Manual Wheelchair are to provide mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K161425
Methodology: https://510kreport.com/methodology