FDA applicant
Tung Keng Enterprise Co., Ltd.
FDA records 6 decisions for Tung Keng Enterprise Co., Ltd. (Hsin-Chu City, TW) from 2003 to 2022: 6 510(k) clearances. Most are in product codes INI (Vehicle, Motorized 3-Wheeled) and ITI (Wheelchair, Powered). Its devices cite 6 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tung Keng Enterprise 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 Tung Keng Enterprise Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Tung”
FDA records each applicant name separately; these may or may not be the same firm.