FDA applicant
Xiamen Weiyou Intelligent Technology Co., Ltd.
FDA records 7 decisions for Xiamen Weiyou Intelligent Technology Co., Ltd. (Xiamen, CN) from 2021 to 2026: 7 510(k) clearances. All are in product code IRP (Massager, Powered Inflatable Tube). Since 2016 its 510(k)s took a median of 184 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 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 Xiamen Weiyou Intelligent Technology 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 2021.
Planning a device like Xiamen Weiyou Intelligent Technology…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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