Helio Kids; Apex P

FDA 510(k) K260295 · Motion Composites

Substantially Equivalent

510(k) numberK260295

Submission

Device name
Helio Kids; Apex P
Applicant
Motion Composites
Saint-Roch-Del’Achigan, CA
Received
January 29, 2026
Decision date
May 28, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IOR – Wheelchair, Mechanical
Device class
Class I (low risk)
Regulation
21 CFR 890.3850
Specialty
Physical Medicine

A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and/or require an assistive device for mobility.

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More from Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.

510(k)DeviceDecision
K161425APEX Manual WheelchairIOR · Traditional 12/05/2016SE
K143101Helio A7 Manual Wheelchair, Move Manual WheelchairIOR · Traditional 05/01/2015SE
K120628HelioIOR · Traditional 12/19/2012SE

Questions and answers

When was Helio Kids; Apex P cleared by the FDA?

Helio Kids; Apex P (K260295) received a 510(k) decision of Substantially Equivalent on May 28, 2026, 119 days after the submission was received.

What is the product code of K260295?

The FDA product code is IOR – Wheelchair, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3850.