FDA applicant
Jiangsu Jumao X-Care Medical Equipment Co., Ltd.
FDA records 8 decisions for Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (Danyang, CN) from 2021 to 2026: 8 510(k) clearances. Most are in product codes IOR (Wheelchair, Mechanical) and CAW (Generator, Oxygen, Portable). Since 2016 its 510(k)s took a median of 111 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices, 1 Class I.
FDA’s records also spell it “Jiangsu Jumao X-Care Medical Equipment Co., , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Jiangsu Jumao X-Care Medical Equipment Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
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