# K120628: HELIO

- Pathway: 510(k) (Traditional)
- Applicant: Motion Composites
- Decided: Dec 19, 2012 after 293 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: 1 generation back to K850536 (1985). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850536: Quickie Wheelchairs, Motion Designs, Inc. (1985) Summary page 1.
- K915533: Quickie Carbon Wheelchair, Sunrise Medical Quickie Designs, Inc. (1992) Summary page 1.

## Most influential descendants
- K161425: APEX Manual Wheelchair (2016), 3 descendants of its own
- 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 hello wheelchair is a manually operated device intended to be used as a means of mobility for persons restricted to a sitting position. It is not indicated for the pediatric population.

Source page: https://510kreport.com/device/K120628
Methodology: https://510kreport.com/methodology