AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830— 510(k) K951037

Name: FDA 510(k) clearance K951037
Creator: U.S. Food and Drug Administration
Published: 1995-03-20

Substantially Equivalent

Akisu Machinery

FDA 510(k) clearance K951037 for AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830, Substantially Equivalent on 1995-03-20. Applicant: Akisu Machinery. Device class: 1.

Clearance details

Applicant: Akisu Machinery
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 1995-03-07
Decision date: 1995-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tai-Chung Hsien, TW

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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.