APEX Manual Wheelchair— 510(k) K161425

Name: FDA 510(k) clearance K161425
Creator: U.S. Food and Drug Administration
Published: 2016-12-05

Substantially Equivalent

Motion Composites

FDA 510(k) clearance K161425 for APEX Manual Wheelchair, Substantially Equivalent on 2016-12-05. Applicant: Motion Composites. Device class: 1.

Clearance details

Applicant: Motion Composites
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2016-05-23
Decision date: 2016-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St-Roch-De-L'Achigan, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code IOR

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K261571 — Manual Wheelchair (H008, PCK7)2026-08-06
K252370 — GEN 4 JOY Wheelchair2026-07-24
K261075 — Manual Wheelchair (MS01); Manual Wheelchair (MA01)2026-06-22
K261076 — Caregiver-assisted wheelchair (MS02); Caregiver-assisted wheelchair (MA02)2026-06-22
K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF2026-06-11

More clearances from Motion Composites

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K260295 — Helio Kids; Apex P2026-05-28
K143101 — Helio A7 Manual Wheelchair, Move Manual Wheelchair2015-05-01
K120628 — HELIO2012-12-19

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.