TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR— 510(k) K033031

Name: FDA 510(k) clearance K033031
Creator: U.S. Food and Drug Administration
Published: 2003-12-02

Substantially Equivalent

Taiwan King Strong Co., Ltd.

FDA 510(k) clearance K033031 for TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR, Substantially Equivalent on 2003-12-02. Applicant: Taiwan King Strong Co., Ltd.. Device class: 1.

Clearance details

Applicant: Taiwan King Strong Co., Ltd.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
Advisory panel: Physical Medicine
Date received: 2003-09-26
Decision date: 2003-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code IOR

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K261571 — Manual Wheelchair (H008, PCK7)2026-08-06
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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

More clearances from Taiwan King Strong Co., Ltd.

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K042652 — TAIWAN KING STRONG TC 04 MECHANICALWHEELCHAIR2004-11-04
K033100 — TAIWAN KING STRONG POWERED WHEELCHAIR, TP 012003-12-02
K033097 — TAIWAN KING STRONG POWERED WHEELCHAIR, TP 022003-11-12

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.