FDA applicant
Gemore Technology Co, Ltd.
FDA records 14 decisions for Gemore Technology Co, Ltd. (Tan Shui, New Taipei City, TW) from 2003 to 2019: 14 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and NGX (Stimulator, Muscle, Powered, For Muscle…). Its devices cite 19 predicates, 6 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 Gemore Technology Co, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Gemore Technology 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) Report