510(k) Report

FDA applicant

Wujiang City Hua Xin Medical Appliance Co., Ltd.

Candler, NC1 decision2002–20020 recalls

FDA records 1 decision for Wujiang City Hua Xin Medical Appliance Co., Ltd. (Candler, NC) in 2002: 1 510(k) clearance. All are in product code MQX (Needle, Acupuncture, Single Use). Its devices cite 2 predicates, 0 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, general hospital panel, where it files most

How often FDA has decided Wujiang City Hua Xin Medical Appliance Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Wujiang City Hua Xin Medical Appliance Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Wujiang City Hua Xin Medical Appliance Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Wujiang”

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