LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI)— 510(k) K944574

Name: FDA 510(k) clearance K944574
Creator: U.S. Food and Drug Administration
Published: 1994-10-17

Substantially Equivalent

Lumex, Inc.

FDA 510(k) clearance K944574 for LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI), Substantially Equivalent on 1994-10-17. Applicant: Lumex, Inc.. Device class: 1.

Clearance details

Applicant: Lumex, Inc.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1994-09-19
Decision date: 1994-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bay Shore, NY, US

Download summary PDF View on FDA.gov ↗

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K945257 — 577ES (ERGOSENSE)1995-04-26

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.