FDA applicant
Fuji Dynamics Limited
FDA records 12 decisions for Fuji Dynamics Limited (Hong Kong, CN) from 2000 to 2016: 12 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and LIH (Interferential Current Therapy). Since 2016 its 510(k)s took a median of 126 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 5 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Fuji Dynamics , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Fuji Dynamics Limited’s devices, and how often a recall has named them.
FDA decisions per year
3in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Fuji Dynamics Limited’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 “Fuji”
FDA records each applicant name separately; these may or may not be the same firm.