FDA applicant
Shenzhen Witleaf Medical Electronics Co., Ltd.
FDA records 2 decisions for Shenzhen Witleaf Medical Electronics Co., Ltd. (Shenzhen, CN) from 2022 to 2023: 2 510(k) clearances. All are in product code DQA (Oximeter). Its devices cite 2 predicates, 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 Shenzhen Witleaf Medical Electronics 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 2022.
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