FDA applicant
Zhenjiang Assure Medical Equipment Co., Ltd.
FDA records 11 decisions for Zhenjiang Assure Medical Equipment Co., Ltd. (Zhenjiang City, CN) from 2012 to 2026: 11 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 11 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
How often FDA has decided Zhenjiang Assure Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Zhenjiang Assure Medical Equipment…’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) ReportOther applicant names beginning “Zhenjiang”
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