FDA applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
FDA records 20 decisions for Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (Dongyang, CN) from 2022 to 2026: 20 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 8 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 Innuovo Rehabilitation Devices Co.,Ltd’s devices, and how often a recall has named them.
FDA decisions per year
5in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
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