FDA applicant
Health & Life Co., Ltd.
FDA records 60 decisions for Health & Life Co., Ltd. (Chung Ho City, Taipei, Hsien, TW) from 1999 to 2021: 60 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 112 days from receipt to decision, against 156 for FDA’s reviews in the same codes and years. Its devices cite 43 predicates, 27 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Health & Life Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2026 so far, outlined.
Recalls per year
1in 2010
Class I Class II/III not classified
Planning a device like Health & Life 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