PRO WALKER ML-300 FOLDABLE WHEELCHAIR— 510(k) K041337

Name: FDA 510(k) clearance K041337
Creator: U.S. Food and Drug Administration
Published: 2004-05-28

Substantially Equivalent

Pro Walker, Inc.

FDA 510(k) clearance K041337 for PRO WALKER ML-300 FOLDABLE WHEELCHAIR, Substantially Equivalent on 2004-05-28. Applicant: Pro Walker, Inc.. Device class: 1.

Clearance details

Applicant: Pro Walker, Inc.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2004-05-19
Decision date: 2004-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

Download summary PDF View on FDA.gov ↗

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K041336 — PRO WALKER PL-200 POWER WHEELCHAIR2004-07-20

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.