TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01— 510(k) K033100

Name: FDA 510(k) clearance K033100
Creator: U.S. Food and Drug Administration
Published: 2003-12-02

Substantially Equivalent

Taiwan King Strong Co., Ltd.

FDA 510(k) clearance K033100 for TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01, Substantially Equivalent on 2003-12-02. Applicant: Taiwan King Strong Co., Ltd.. Device class: 2.

Clearance details

Applicant: Taiwan King Strong Co., Ltd.
Product code: Code ITI
Device class: Class 2
Regulation: 21 CFR 890.3860
Advisory panel: Physical Medicine
Date received: 2003-09-29
Decision date: 2003-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

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More clearances from Taiwan King Strong Co., Ltd.

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K042652 — TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR2004-11-04
K033031 — TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR2003-12-02
K033097 — TAIWAN KING STRONG POWERED WHEELCHAIR, TP 022003-11-12

Adverse events under product code ITI

product code ITI

Death: 34
Injury: 778
Malfunction: 1,085
Other: 1
Total: 1,898

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.