FDA applicant
Merits Health Products Co., Ltd.
FDA records 31 decisions for Merits Health Products Co., Ltd. (Taichung, TW) from 1993 to 2022: 31 510(k) clearances. Most are in product codes ITI (Wheelchair, Powered) and INI (Vehicle, Motorized 3-Wheeled). Its devices cite 23 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Merits Health Products., Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Merits Health 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
2in 2021
Class I Class II/III not classified
Planning a device like Merits Health 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.
See the 510(k) ReportOther applicant names beginning “Merits”
FDA records each applicant name separately; these may or may not be the same firm.