FDA applicant
Zens Health Care Products
FDA records 1 decision for Zens Health Care Products (Walker, MI) in 1984: 1 510(k) clearance. All are in product code FQM (Bandage, Elastic). 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 Zens Health Care Products’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Zens Health Care Products since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Zens Health Care Products’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