510(k) Report

FDA applicant

Taiwan an I Co., Ltd.

Littleton, CO2 decisions2001–20050 recalls

FDA records 2 decisions for Taiwan an I Co., Ltd. (Littleton, CO) from 2001 to 2005: 2 510(k) clearances. All are in product code IOR (Wheelchair, Mechanical). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Taiwan an I Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Taiwan an I Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Taiwan an I Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Taiwan an I Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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