510(k) K161055 · KPI Stimulator, Electrical, Non-Implantable, For Incontinence

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

Applicant	Fuji Dynamics , Ltd., Hong Kong, CN
Decision	Substantially Equivalent, Jul 12, 2016
Received	Apr 14, 2016
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K161055

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.