FDA applicant
Jiangxi Royall Smart Technology Co., Ltd.
FDA records 1 decision for Jiangxi Royall Smart Technology Co., Ltd. (Ganzhou, CN) in 2023: 1 510(k) clearance. All are in product code NUH (Stimulator, Nerve, Transcutaneous…). 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 Jiangxi Royall Smart Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
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