FDA applicant
Heartway Medical Products Co., Ltd.
FDA records 23 decisions for Heartway Medical Products Co., Ltd. (Hsin-Chu City, TW) from 1997 to 2022: 23 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Its devices cite 22 predicates, 19 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 Heartway Medical Products Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Heartway Medical Products Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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