FDA applicant
Long Train Enterprise Co., Ltd.
FDA records 1 decision for Long Train Enterprise Co., Ltd. (Taichung, TW) in 1995: 1 510(k) clearance. All are in product code HQY (Sunglasses (Non-Prescription Including…). 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 Long Train Enterprise Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Long Train Enterprise Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Long Train 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 “Long”
FDA records each applicant name separately; these may or may not be the same firm.