FDA applicant
Well-Life Healthcare Limited
FDA records 29 decisions for Well-Life Healthcare Limited (Yunghe City, Taipei County, TW) from 2002 to 2026: 29 510(k) clearances. Most are in product codes NUH (Stimulator, Nerve, Transcutaneous…) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Since 2016 its 510(k)s took a median of 162 days from receipt to decision, against 145 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 18 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Well-Life Healthcare, Inc.”, “Well-Life Healthcare , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Well-Life Healthcare Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Well-Life Healthcare Limited’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-Life”
FDA records each applicant name separately; these may or may not be the same firm.