FDA applicant
ChangSha ChuangDuoLe E-Commerce Co., Ltd.
FDA records 1 decision for ChangSha ChuangDuoLe E-Commerce Co., Ltd. (Changsha, CN) in 2026: 1 510(k) clearance. All are in product code OBR (Mouthguard, Over-The-Counter). 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 ChangSha ChuangDuoLe E-Commerce Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like ChangSha ChuangDuoLe E-Commerce Co.…’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 “ChangSha”
FDA records each applicant name separately; these may or may not be the same firm.