FDA applicant
Everyway Medical Instruments Co.,Ltd
FDA records 29 decisions for Everyway Medical Instruments Co.,Ltd (Roswell, GA) from 2001 to 2025: 29 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and GXY (Electrode, Cutaneous). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 135 for FDA’s reviews in the same codes and years. Its devices cite 20 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 Everyway Medical Instruments 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 2007.
Planning a device like Everyway Medical Instruments 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) ReportOther applicant names beginning “Everyway”
FDA records each applicant name separately; these may or may not be the same firm.