# K260295: Helio Kids; Apex P

- Pathway: 510(k) (Traditional)
- Applicant: Motion Composites
- Decided: May 28, 2026 after 119 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: 3 generations back to K850536 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120628: HELIO, Motion Composites (2012) Summary page 5.
- K143101: Helio A7 Manual Wheelchair, Move Manual Wheelchair, Motion Composites (2015) Summary page 5.
- K161425: APEX Manual Wheelchair, Motion Composites (2016) Summary page 5.
- K223527: Little Wave Clik, Rogue XP, Little Wave XP, Spark, Ki Mobility, LLC (2023) Summary page 5.

## Indications for use
Helio Kids: The Helio Kids is indicated as a manual wheelchair to provide mobility for pediatric persons (23 kg to 75 kg) limited to a sitting position. Apex P: The Apex P is indicated as a manual wheelchair to provide mobility for pediatric persons (23 kg to 75 kg) limited to a sitting position.

Source page: https://510kreport.com/device/K260295
Methodology: https://510kreport.com/methodology