510(k) Report

FDA applicant

Teh Lin Prosthetic & Orthopaedic, Inc.

Hsin Chu City, TW9 decisions2002–20050 recalls

FDA records 9 decisions for Teh Lin Prosthetic & Orthopaedic, Inc. (Hsin Chu City, TW) from 2002 to 2005: 9 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Its devices cite 6 predicates, 6 of them its own earlier devices. 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 Teh Lin Prosthetic & Orthopaedic, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Teh Lin Prosthetic & Orthopaedic, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Teh Lin Prosthetic & Orthopaedic, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Teh Lin Prosthetic & Orthopaedic, Inc.’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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