FDA applicant
Well Brain International, Ltd.
FDA records 4 decisions for Well Brain International, Ltd. (Hong Kong, CN) from 2012 to 2021: 4 510(k) clearances. All are in product code NGX (Stimulator, Muscle, Powered, For Muscle…). Its devices cite 9 predicates, 3 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 Well Brain International, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Well Brain International, 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 “Well”
FDA records each applicant name separately; these may or may not be the same firm.