Helio Kids; Apex P— 510(k) K260295
Substantially EquivalentMotion Composites
FDA 510(k) clearance K260295 for Helio Kids; Apex P, Substantially Equivalent on 2026-05-28. Applicant: Motion Composites. Device class: 1.
Summary
Motion Composites' record covers two items, Helio Kids and Apex P, under IOR, mechanical wheelchairs.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Motion Composites filed from Canada (the city in the record has a garbled character). The decision came 119 calendar days after receipt (January 29 to May 28, 2026).
Clearance details
- Applicant
- Motion Composites
- Product code
- Product code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint-Roch-DelAchigan, CA
Recent devices under product code IOR
view allMore clearances from Motion Composites
view allAdverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.