FDA applicant

Comfort Orthopedic Co., Ltd.

Hsin-Chu City,, TW13 decisions2002–20100 recalls

FDA records 13 decisions for Comfort Orthopedic Co., Ltd. (Hsin-Chu City,, TW) from 2002 to 2010: 13 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and IPL (Wheelchair, Standup). Its devices cite 5 predicates, 5 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 Comfort Orthopedic Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Comfort”

FDA records each applicant name separately; these may or may not be the same firm.

Comfort Rubber Gloves Industries Sdn. Bhd. 15 Comfort Acrylics Co. 3 Comfort Rubber Gloves Ind. Sdn. Bhd. 2 Comfort Strap Co. 1 Comfort and Flexible Systems 1

Comfort Orthopedic Co., Ltd.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Comfort”