FDA applicant
Wuhan Zoncare Bio-medical Electronics Co., Ltd.
FDA records 1 decision for Wuhan Zoncare Bio-medical Electronics Co., Ltd. (Wuhan, CN) in 2019: 1 510(k) clearance. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). 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 Wuhan Zoncare Bio-medical Electronics Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
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