FDA applicant
Reno Medical, Ltd.
FDA records 2 decisions for Reno Medical, Ltd. (Hongkong, CN) from 2010 to 2017: 2 510(k) clearances. All are in product code GXY (Electrode, Cutaneous). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Reno Medical Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Reno Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Reno Medical, 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