FDA applicant

Changsha Yuwen Medical Equipment Co., Ltd.

Changsha, CN4 decisions2022–20230 recalls

FDA records 4 decisions for Changsha Yuwen Medical Equipment Co., Ltd. (Changsha, CN) from 2022 to 2023: 4 510(k) clearances. All are in product code NUH (Stimulator, Nerve, Transcutaneous…). Since 2016 its 510(k)s took a median of 70 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. 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, neurology panel, where it files most

How often FDA has decided Changsha Yuwen Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2022high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Changsha Yuwen Medical Equipment Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Changsha Yuwen Medical Equipment Co.…’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 “Changsha”

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

Changsha Anxiang Medical Technology Co., Ltd. 8 Changsha Sinocare, Inc. 1 Changsha Honchon Technology Co., Ltd. 1 ChangSha ChuangDuoLe E-Commerce Co., Ltd. 1

Changsha Yuwen Medical Equipment Co., Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

What has FDA decided for it lately?

Other applicant names beginning “Changsha”