FDA applicant
Shandong Guyue Healthcare Appliance Co., Ltd.
FDA records 1 decision for Shandong Guyue Healthcare Appliance Co., Ltd. (Binzhou, CN) in 2025: 1 510(k) clearance. All are in product code ITI (Wheelchair, Powered). Its devices cite 1 predicate, 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 Shandong Guyue Healthcare Appliance Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
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