FDA applicant
Zhangzhou Easepal Medical Science and Technology Co., Ltd.
FDA records 3 decisions for Zhangzhou Easepal Medical Science and Technology Co., Ltd. (Zhangzhou, CN) from 2022 to 2024: 3 510(k) clearances. Most are in product codes IRP (Massager, Powered Inflatable Tube) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 223 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 1 predicate, 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
How often FDA has decided Zhangzhou Easepal Medical Science and Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Zhangzhou Easepal Medical Science and…’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 “Zhangzhou”
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