FDA applicant
Enchant Tek Co., Ltd.
FDA records 2 decisions for Enchant Tek Co., Ltd. (Yilan County, TW) from 2024 to 2025: 2 510(k) clearances. Most are in product codes CAF (Nebulizer (Direct Patient Interface)) and BWF (Spirometer, Therapeutic (Incentive)). Its devices cite 2 predicates, 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 Enchant Tek 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 2024.
Planning a device like Enchant Tek 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) Report