FDA applicant
Yurob Rehabilitation Medical Co., Ltd.
FDA records 4 decisions for Yurob Rehabilitation Medical Co., Ltd. (Kunshan, CN) from 2023 to 2026: 4 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and INI (Vehicle, Motorized 3-Wheeled). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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 Yurob Rehabilitation Medical 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 2023.
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