FDA applicant

Kunshan Hi-Fortune Health Products Co., Ltd.

Kunshan, CN9 decisions2017–20250 recalls

FDA records 9 decisions for Kunshan Hi-Fortune Health Products Co., Ltd. (Kunshan, CN) from 2017 to 2025: 9 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and IOR (Wheelchair, Mechanical). Since 2016 its 510(k)s took a median of 157 days from receipt to decision, against 96 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 2 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 Kunshan Hi-Fortune Health Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2017high 3 (2025) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Kunshan Hi-Fortune Health Products Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kunshan Hi-Fortune Health Products…’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 “Kunshan”

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

Kunshan Jiehong Nonwoven Product Co., Ltd. 2 Kunshan Aoshida Electric Technology Co., Ltd. 1 Kunshan Deyi Plastic Co., Ltd. 1 Kunshan Bella Optical Technology Co., Ltd. 1

Kunshan Hi-Fortune Health Products Co., Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Kunshan”