FDA applicant
Wavepulse (Xiamen) Healthcare Technology Co., Ltd.
FDA records 1 decision for Wavepulse (Xiamen) Healthcare Technology Co., Ltd. (Xiamen, CN) in 2026: 1 510(k) clearance. All are in product code IRP (Massager, Powered Inflatable Tube). 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 Wavepulse (Xiamen) Healthcare Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
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