FDA applicant
Wuxi Jiajian Medical Instrument Co., Ltd.
FDA records 12 decisions for Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN) from 2009 to 2025: 12 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and BWK (Stimulator, Electro-Acupuncture). Since 2016 its 510(k)s took a median of 315 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 4 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 Wuxi Jiajian Medical Instrument Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Wuxi Jiajian Medical Instrument 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 “Wuxi”
FDA records each applicant name separately; these may or may not be the same firm.