FDA applicant
Iweecare Co., Ltd.
FDA records 2 decisions for Iweecare Co., Ltd. (Taipei City, TW) from 2021 to 2023: 2 510(k) clearances. All are in product code FLL (Continuous Measurement Thermometer). Its devices cite 2 predicates, 1 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 Iweecare Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2021high 1 (2021) · low 0 (2022)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Iweecare 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