X2000 TRADITIONAL WHEELCHAIR— 510(k) K951351

Name: FDA 510(k) clearance K951351
Creator: U.S. Food and Drug Administration
Published: 1995-04-26

Substantially Equivalent

Homecrest Industries

FDA 510(k) clearance K951351 for X2000 TRADITIONAL WHEELCHAIR, Substantially Equivalent on 1995-04-26. Applicant: Homecrest Industries. Device class: 1.

Clearance details

Applicant: Homecrest Industries
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1995-03-23
Decision date: 1995-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IOR

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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

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.