Cleared Traditional

K260295 - Helio Kids

Also marketed or referenced as:
Apex P

K260295 is an FDA 510(k) clearance for Helio Kids, manufactured by Motion Composites. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K260295 · Motion Composites · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
119d
Days
Class 1
Risk

K260295 is an FDA 510(k) clearance for the Helio Kids. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Motion Composites (Saint-Roch-Del’Achigan, CA). The FDA issued a Cleared decision on May 28, 2026 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Motion Composites devices

FDA 510(k) Submission Details - K260295

510(k) Number K260295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2026
Decision Date May 28, 2026
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 220
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K260295.
Caregiver-assisted wheelchair (MS02)
K261076 · GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. · Jun 2026
ICON 35
K260849 · Rehasense USA, Inc. · Jun 2026
Manual Wheelchair (LW01108)
K260642 · Anhui Longway Medical Technology Co., Ltd. · Jun 2026
Manual Wheelchair (DY01903(2))
K254141 · Guangdong Dayang Medical Technology Co., Ltd. · May 2026
Manual Wheelchair (7101L, 7102LHD)
K260121 · Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · Apr 2026
Manual Wheelchair (W50)
K253632 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Jan 2026