FDA applicant
Zhejiang Zhonglei Medical Technology Co., Ltd.
FDA records 3 decisions for Zhejiang Zhonglei Medical Technology Co., Ltd. (Lishui, CN) in 2024: 3 510(k) clearances. All are in product code ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 97 days from receipt to decision, against 125 for FDA’s reviews in the same codes and years. 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 Zhejiang Zhonglei Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
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